GEMSCOM SERIES 3000

Transmitters And Receivers, Physiological Signal, Radiofrequency

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 3000.

Pre-market Notification Details

Device IDK914889
510k NumberK914889
Device Name:GEMSCOM SERIES 3000
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-31
Decision Date1992-03-04

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