GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300

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 6000, Models 6100, 6200 & 6300.

Pre-market Notification Details

Device IDK940009
510k NumberK940009
Device Name:GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-04
Decision Date1995-04-14

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