FDA 510(k) Applications for Medical Device Product Code "DTA"
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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 |
K163008 | Medtronic, Inc. | CareLink SmartSync Device Manager - Pacing System Analyzer | 02/28/2017 |
K050884 | REMINGTON MEDICAL, INC. | ADAPTER CABLE | 05/19/2005 |
K101982 | ST JUDE MEDICAL, CRMD | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | 12/21/2010 |