Siemens Elema AB
Medical device manufacturer in Danvers, MA.
63510(k) clearances
0PMA approvals
0recalls
Device types
- CBK Ventilator, Continuous, Facility Use 15
- DXY Implantable Pacemaker Pulse-Generator 15
- DTB Permanent Pacemaker Electrode 3
- BTI Compressor, Air, Portable 2
- DPS Electrocardiograph 2
- BYD Condenser, Heat And Moisture (Artificial… 2
- CAF Nebulizer (Direct Patient Interface) 2
- DQK Computer, Diagnostic, Programmable 2
- BZR Mixer, Breathing Gases, Anesthesia Inhalation 2
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- KRE Analyzer, Pacemaker Generator Function… 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
- BZN Cart, Emergency, Cardiopulmonary (Excluding… 1
- BZO Set, Tubing And Support, Ventilator (W… 1
- CAM Yoke Assembly, Medical Gas 1
- CAD Vaporizer, Anesthesia, Non-Heated 1
- DJH Gas Chromatography, Phenobarbital 1
- BZL Computer, Oxygen-Uptake 1
- DTD Pacemaker Lead Adaptor 1
- MHX Monitor, Physiological, Patient(With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81EBTI · Traditional | 09/05/2003SE |
| K010923 | Kion Anaesthesia System, Model 65 03 879 E392EMHX · Abbreviated | 01/23/2002SE |
| K010925 | Servoi Ventilator System, Model 64 87 800 E407ECBK · Abbreviated | 12/18/2001SE |
| K002137 | Cathcor DesktopDQK · Traditional | 10/05/2000SE |
| K001315 | Modification to Kion Anesthesia SystemBSZ · Special | 05/26/2000SE |
| K970839 | Servo Ventilator 300ACBK · Traditional | 10/14/1997ST |
| K960168 | Siemens Servo Screen 390 and Servo Computer Module 990CBK · Traditional | 10/25/1996ST |
| K960010 | Servo Ventilator 300 Computer InterfaceCBK · Traditional | 10/25/1996ST |
| K872278 | Siemens O2-AIR Mixer 965BZR · Traditional | 09/03/1987SE |
| K871354 | Servo Ventilator 900 C/DCBK · Traditional | 07/21/1987SE |
| K871829 | Siemens Dry Air CompressorBTI · Traditional | 06/15/1987SE |
| K871366 | Siemens Main Flow Bacteria FilterCAH · Traditional | 05/14/1987SE |
| K871293 | Servo Nebulizer 945 Siemens-Elema ABCAF · Traditional | 05/08/1987SE |
| K864105 | Lung Mechanics Software ProgramCBK · Traditional | 11/07/1986SE |
| K863675 | Calibration Gas for Servo Gas Monitor 120BXK · Traditional | 11/03/1986SE |
| K861707 | Master Program Flow & Pressure CO2 & Lung MonitorCBK · Traditional | 06/19/1986SE |
| K861625 | Servo Gas Monitor 120CCL · Traditional | 05/02/1986SE |
| K854036 | Manual Ventilation Accessory · Traditional | 10/23/1985SE |
| K852772 | Gas Evacuation AccessoryCBN · Traditional | 10/10/1985SE |
| K852771 | PC InterfaceCBK · Traditional | 10/10/1985SE |
| K852601 | Servo Humidifier 153BYD · Traditional | 07/08/1985SE |
| K851044 | Cardiostat 3 RecorderDPS · Traditional | 06/26/1985SE |
| K850374 | Connection Cable for Synchronization of Two ServoCBK · Traditional | 04/25/1985SE |
| K844392 | Cardiostat 1 ECG RecorderDPS · Traditional | 04/11/1985SE |
| K844912 | Servo Ventilator 900D Siemens-Elema ABCBK · Traditional | 12/28/1984SE |
| K841232 | Pulse Generator 696, 696B & 696LDXY · Traditional | 12/03/1984SE |
| K841230 | Pulse Generator 686, 686B 686LDXY · Traditional | 12/03/1984SE |
| K841225 | Pulse Generator 689, 689B & 689LDXY · Traditional | 12/03/1984SE |
| K844590 | Power Pack 160 Siemens-Elema ABCBK · Traditional | 11/29/1984SE |
| K841227 | Bipolar Endocardial Lead 406LDTD · Traditional | 11/27/1984SE |
| K844040 | Servo Humidifier 152 Siemens-Elema ABBYD · Traditional | 10/25/1984SE |
| K843440 | Mingo Log 7DJH · Traditional | 09/04/1984SE |
| K841233 | Pulse Generator 678LDXY · Traditional | 07/06/1984SE |
| K841231 | Pulse Generator 688B & 688LDXY · Traditional | 06/26/1984SE |
| K841228 | Pulse Generator 718B & 718LDXY · Traditional | 06/26/1984SE |
| K841226 | Pulse Generator 728, 728B & 728LDXY · Traditional | 06/26/1984SE |
| K841229 | Pulse Generator 698, 698B & 698LDXY · Traditional | 06/25/1984SE |
| K841157 | Halothane Vaporizer 950, EnfluraneCAD · Traditional | 06/07/1984SE |
| K840326 | Gas Supply Manifold Siemens-Elema ABCAM · Traditional | 06/07/1984SE |
| K841657 | Patient Tubing Hytrel Siemens-ElemaBZO · Traditional | 05/23/1984SE |
| K841529 | Siemens-Elema Ventilator 900CCBK · Traditional | 05/23/1984SE |
| K841393 | AB Manual Ventilation Access. 900CCBK · Traditional | 05/21/1984SE |
| K840264 | Servo Cart 170BZN · Traditional | 02/04/1984SE |
| K832898 | Nebulizer Accessory for Servo VentillCAF · Traditional | 11/25/1983SE |
| K832959 | Pacemaker Sys. Analyzer 378KRE · Traditional | 11/14/1983SE |
| K822213 | Siemens-Elema AB Aga RevivatorBTM · Traditional | 10/28/1982SE |
| K820657 | Pulse Generator 678 BDXY · Traditional | 04/15/1982SE |
| K820767 | Biopolar Tined Endocardial Lead 403B/60DTB · Traditional | 04/09/1982SE |
| K813576 | Siemens-Elema Pulse Generator 659DXY · Traditional | 01/22/1982SE |
| K811102 | Siemens-Elema AB Servo Ventilator 900 CCBK · Traditional | 05/05/1981SE |
| K802864 | Siemens-Elema Pulse Generator 678DXY · Traditional | 02/05/1981SE |
| K801810 | Pacemaker Patient Mgmt. SystemDQK · Traditional | 02/05/1981SE |
| K810036 | Siemens-Elema Myocardial LeadDXY · Traditional | 01/29/1981SE |
| K802816 | Endocardial Leads 414S & 515SDTB · Traditional | 01/16/1981SE |
| K803042 | Siemens-Elema Endocardial Lead 402SDTB · Traditional | 12/22/1980SE |
| K801324 | Siemens-Elema Pulse Generator 668DXY · Traditional | 12/01/1980SE |
| K802459 | Siemens-Elema AB CO2 Monitor 130CCK · Traditional | 10/23/1980SE |
| K802417 | AB O2 Consumption Calculator 980BZL · Traditional | 10/23/1980SE |
| K801508 | Siemens-Elema Pulse Generator 625DXY · Traditional | 09/16/1980SE |
| K800905 | Siemens-Elema AB O2-AIR Mixer 960BZR · Traditional | 05/08/1980SE |
| K800387 | Pulse Generators Models 657 & 677DXY · Traditional | 05/02/1980SE |
| K800114 | Siemens-Elema AB Manual VentilationCBK · Traditional | 03/05/1980SE |
| K781496 | Ximatron IVKPQ · Traditional | 09/14/1978SE |