Pulse Generator 696, 696B & 696L
FDA 510(k) K841232 · Siemens Elema AB
510(k) numberK841232
Submission
- Device name
- Pulse Generator 696, 696B & 696L
- Applicant
- Siemens Elema AB
Mchenry, IL, US - Received
- March 22, 1984
- Decision date
- December 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXY – Implantable Pacemaker Pulse-Generator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3610
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | Biotronik, Inc. | 11/10/1999SE |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | Ela Medical, Inc. | 08/29/1997ST |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | Biotronik, Inc. | 03/04/1996SESP |
| K954092 | Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953866 | Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | Cook Pacemaker Corp. | 09/29/1995ST |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | Biotronik, Inc. | 09/29/1995ST |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | Ela Medical, Inc. | 09/01/1995ST |
| K940039 | Pellethane 75DDXY · Traditional | Medtronic Vascular | 07/12/1995ST |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional | Medtronic Vascular | 05/15/1995ST |
More from Medtronic Vascular
| 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 |
Questions and answers
When was Pulse Generator 696, 696B & 696L cleared by the FDA?
Pulse Generator 696, 696B & 696L (K841232) received a 510(k) decision of Substantially Equivalent on December 3, 1984, 256 days after the submission was received.
What is the product code of K841232?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.