FDA Product Code
FDA Product Code DTA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3720
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017-02-28 | Traditional | PDF ↗ |
| K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | St Jude Medical, Crmd | 2010-12-21 | Traditional | PDF ↗ |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | 2007-12-20 | Special | PDF ↗ |
| K050884 | ADAPTER CABLE | Remington Medical, Inc. | 2005-05-19 | Traditional | PDF ↗ |
| K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | 2003-12-08 | Special | PDF ↗ |
| K022360 | 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. | Biotronik, Inc. | 2003-01-27 | Traditional | PDF ↗ |
| K933069 | MODEL EP-2 CLINICAL STIMULATOR | Ep Medical, Inc. | 1993-10-21 | Traditional | PDF ↗ |
| K812104 | SIEMENS-ELEMA PSA 376 | Siemens Corp. | 1981-12-02 | Traditional | PDF ↗ |
| K791380 | VA 1000 | Vitatron Medical BV | 1979-09-19 | Traditional | PDF ↗ |
| K790503 | CARDIOTEST 2200 | Cardiac Pacemakers, Inc. | 1979-05-17 | Traditional | PDF ↗ |
Product code DTA · Class II · Cardiovascular. Data: openFDA.