Tester, Pacemaker Electrode Function
FDA product code DTA · Class II (moderate risk) · 21 CFR 870.3720 · Cardiovascular
10510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System AnalyzerDTA · Traditional | Medtronic, Inc. | 02/28/2017SE |
| K101982 | Merlin Psa Patient Cable Ex 3150, Cable Adapter EX3170, M Adapter EX3180DTA · Traditional | St Jude Medical, Crmd | 12/21/2010SE |
| K073230 | Models Era 300 and 3105 Pacing System AnalyzersDTA · Special | Biotronik, Inc. | 12/20/2007SE |
| K050884 | Adapter CableDTA · Traditional | Remington Medical, Inc. | 05/19/2005SE |
| K033613 | Modification to Era 300 Dual Chamber Pacing System AnalyzerDTA · Special | Biotronik, Inc. | 12/08/2003SE |
| K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…DTA · Traditional | Biotronik, Inc. | 01/27/2003SE |
| K933069 | Model EP-2 Clinical StimulatorDTA · Traditional | Ep Medical, Inc. | 10/21/1993SE |
| K812104 | Siemens-Elema Psa 376DTA · Traditional | Siemens Corp. | 12/02/1981SE |
| K791380 | Va 1000DTA · Traditional | Vitatron Medical BV | 09/19/1979SE |
| K790503 | Cardiotest 2200DTA · Traditional | Cardiac Pacemakers, Inc. | 05/17/1979SE |