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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