GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

Transmitters And Receivers, Electrocardiograph, Telephone

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 300 12-lead Ecg (12-lead Option).

Pre-market Notification Details

Device IDK921929
510k NumberK921929
Device Name:GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-24
Decision Date1992-09-18

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