CARDIOTEST 2200

Tester, Pacemaker Electrode Function

CARDIAC PACEMAKERS, INC.

The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Cardiotest 2200.

Pre-market Notification Details

Device IDK790503
510k NumberK790503
Device Name:CARDIOTEST 2200
ClassificationTester, Pacemaker Electrode Function
Applicant CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTA  
CFR Regulation Number870.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-13
Decision Date1979-05-17

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