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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 K914889
Device Name GEMSCOM SERIES 3000
Applicant
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Correspondent Contact MICHAEL SMITH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/31/1991
Decision Date 03/04/1992
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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