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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K940009
Device Name GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
Applicant
General Devices
1000 River St.
Ridgefield,  NJ  07657
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
1000 River St.
Ridgefield,  NJ  07657
Correspondent Contact MICHAEL SMITH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received01/04/1994
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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