Nellcor Puritan Bennett, Inc.
Medical device manufacturer in Pleasanton, CA.
43510(k) clearances
1PMA approvals
1recalls
Device types
- DQA Oximeter 19
- CBK Ventilator, Continuous, Facility Use 5
- BTM Ventilator, Emergency, Manual (Resuscitator) 3
- BZD Ventilator, Non-Continuous (Respirator) 3
- DPS Electrocardiograph 2
- LRK Device, Anti-Snoring 2
- MNR Ventilatory Effort Recorder 2
- DWJ System, Thermal Regulating 2
- BZG Spirometer, Diagnostic 1
- BZK Spirometer, Monitoring (W/Wo Alarm) 1
- CAF Nebulizer (Direct Patient Interface) 1
- JOH Tube Tracheostomy And Tube Cuff 1
- NLF Oximeter, Reprocessed 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K070899 | Puritan Bennett Legendair XL2CBK · Traditional | 12/13/2007SE |
| K070408 | Duramax Reusable Oximetry SensorDQA · Abbreviated | 05/25/2007SE |
| K060576 | Nellcor Oximax N-600X Pulse OximeterDQA · Traditional | 08/14/2006SE |
| K051271 | Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorDQA · Traditional | 01/10/2006SE |
| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | 12/13/2004SE |
| K030787 | Shiley Flextra Tracheostomy TubeJOH · Traditional | 11/14/2003SE |
| K030930 | Oximax Softcare Sensors, Models Sc-A, Sc-Pr, Sc-Neo, Sc-NDQA · Traditional | 05/23/2003SE |
| K023494 | Nellcor Indgo Manual ResuscitatorBTM · Special | 02/07/2003SE |
| K022819 | Nellcor N-200 Pulse Oximeter, Model N-200DQA · Special | 09/24/2002SE |
| K020357 | 800 Series Easyneb NebulizerCAF · Traditional | 08/07/2002SE |
| K021089 | Oximax Max-Fast Adhesive Forehead SensorDQA · Traditional | 06/19/2002SE |
| K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterDQA · Special | 05/08/2002SE |
| K020604 | Warmtouch Patient Warming System, Model 5300DWJ · Special | 04/23/2002SE |
| K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…DQA · Traditional | 03/07/2002SE |
| K014121 | Warmtouch Cardiac Blanket,Catalog # 503-0860DWJ · Special | 01/11/2002SE |
| K002686 | Achieva Ventilator Y-Ach+E, Achieva PS Ventilator Y-Achps+E, Achieva PSO2 Ventilator…CBK · Special | 10/18/2000ST |
| K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsDQA · Special | 11/24/1999SE |
| K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorCBK · Traditional | 11/18/1999ST |
| K991823 | N-395 Pulse Oximeter, Model N-395DQA · Traditional | 08/25/1999SE |
| K990565 | SuzanneMNR · Traditional | 08/18/1999SE |
| K983274 | Startrack Infant Graphics MonitorBZK · Traditional | 12/09/1998SE |
| K982728 | Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CDQA · Traditional | 12/07/1998SE |
| K980365 | Goodknight 418 CPAP SystemBZD · Traditional | 07/22/1998SE |
| K980441 | Spirometer Model NPB-500BZG · Traditional | 04/30/1998SE |
| K973419 | DMR Plus Disposable Manual ResuscitatorBTM · Traditional | 03/25/1998SE |
| K973147 | NPB-295 Pulse OximeterDQA · Traditional | 11/14/1997SE |
| K972837 | NPB-290 Pulse Oximeter (NPB-290)DQA · Traditional | 10/21/1997SE |
| K972468 | NPB-195 Pulse OximeterDQA · Traditional | 09/25/1997SE |
| K972248 | Nellcor Puritan Bennett GeminiCBK · Traditional | 09/12/1997ST |
| K971946 | NPB-190 Pulse Oximeter (NPB-190)DQA · Traditional | 08/25/1997SE |
| K964019 | Morphee Plus AlphaBZD · Traditional | 06/18/1997SE |
| K964543 | Infrasonics Adult Ventilator Trending OptionCBK · Traditional | 02/14/1997ST |
| K964494 | SleepwizardMNR · Traditional | 02/04/1997SE |
| K964516 | TapLRK · Traditional | 01/24/1997SE |
| K963707 | Nellcor Puritan Bennett NPB-40 Handheld PULSE(NPB-40)DQA · Traditional | 12/13/1996SE |
| K963400 | Nellcor Symphony N-3000 Patient Monitor with SPO2 and ECG and N-3200 Display/PrinterDPS · Traditional | 11/26/1996SE |
| K962516 | Tap Anti-Snoring DeviceLRK · Traditional | 09/10/1996SE |
| K961450 | Score SoftwareDQA · Traditional | 08/01/1996SE |
| K955642 | Nellcor Symphony N-3000 Patient Monitor W/SP02 & ECG/N-3200 Display/PrinterDPS · Traditional | 07/02/1996SE |
| K960468 | DMR/CO2 Combo KtiBTM · Traditional | 04/26/1996SESK |
PMA approvals
- P880013 Infant Star High Frequency Ventilator · 01/19/1990 · 6 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0760-2007 | Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX…In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does… | 03/12/2007Terminated |