PREP-CHECK

Tester, Electrode, Surface, Electrocardiographic

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Prep-check.

Pre-market Notification Details

Device IDK830876
510k NumberK830876
Device Name:PREP-CHECK
ClassificationTester, Electrode, Surface, Electrocardiographic
Applicant GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
Product CodeKRC  
CFR Regulation Number870.2370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-18
Decision Date1983-05-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862186000317 K830876 000
00862186000300 K830876 000

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