EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)

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 Ems Telemedicine Option (for Gems Series 4000).

Pre-market Notification Details

Device IDK013533
510k NumberK013533
Device Name:EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
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 Received2001-10-23
Decision Date2002-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862186000379 K013533 000

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