CG-1000 PERSONAL ECG TRANSMITTER

Transmitters And Receivers, Electrocardiograph, Telephone

CARD GUARD SCIENTIFIC SURVIVAL, LTD.

The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Cg-1000 Personal Ecg Transmitter.

Pre-market Notification Details

Device IDK935909
510k NumberK935909
Device Name:CG-1000 PERSONAL ECG TRANSMITTER
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
CARD GUARD SCIENTIFIC SURVIVAL, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington,  DC  20004 -1109
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-09
Decision Date1995-04-28

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