FDA 510(k) Applications for Medical Device Product Code "DTA"
(Tester, Pacemaker Electrode Function)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K022360 | BIOTRONIK, INC. | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. | 01/27/2003 |
| K073230 | BIOTRONIK, INC. | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | 12/20/2007 |
| K033613 | BIOTRONIK, INC. | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | 12/08/2003 |
| K790503 | CARDIAC PACEMAKERS, INC. | CARDIOTEST 2200 | 05/17/1979 |
| K933069 | EP MEDICAL, INC. | MODEL EP-2 CLINICAL STIMULATOR | 10/21/1993 |
| K163008 | Medtronic, Inc. | CareLink SmartSync Device Manager - Pacing System Analyzer | 02/28/2017 |
| K050884 | REMINGTON MEDICAL, INC. | ADAPTER CABLE | 05/19/2005 |
| K812104 | SIEMENS CORP. | SIEMENS-ELEMA PSA 376 | 12/02/1981 |
| K101982 | ST JUDE MEDICAL, CRMD | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | 12/21/2010 |
| K791380 | VITATRON MEDICAL BV | VA 1000 | 09/19/1979 |
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