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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