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DTA — Tester, Pacemaker Electrode Function Class II

FDA Device Classification

Classification Details

Product Code
DTA
Device Class
Class II
Regulation Number
870.3720
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K163008medtronicCareLink SmartSync Device Manager - Pacing System AnalyzerFebruary 28, 2017
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K073230biotronikMODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERSDecember 20, 2007
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K033613biotronikMODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERDecember 8, 2003
K022360biotronikERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA January 27, 2003
K933069ep medicalMODEL EP-2 CLINICAL STIMULATOROctober 21, 1993
K812104siemensSIEMENS-ELEMA PSA 376December 2, 1981
K791380vitatron medicalVA 1000September 19, 1979
K790503cardiac pacemakersCARDIOTEST 2200May 17, 1979