PACEMAKER PROGRAMMER 2030

Programmer, Pacemaker

CARDIAC PACEMAKERS, INC.

The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Pacemaker Programmer 2030.

Pre-market Notification Details

Device IDK820230
510k NumberK820230
Device Name:PACEMAKER PROGRAMMER 2030
ClassificationProgrammer, Pacemaker
Applicant CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRG  
CFR Regulation Number870.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-28
Decision Date1982-03-15

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