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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 K030795
Device Name LIFESYNE SYSTEMS
Original Applicant
GMP/COMPANIES, INC.
one east broward blvd.
suite 1701
fort lauderdale,  FL  33301
Original Contact ralph jugo
Regulation Number870.2910
Classification Product Code
DRG  
Date Received03/12/2003
Decision Date 08/05/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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