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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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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