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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, ear
510(k) Number K914595
Device Name PULSE RATE MONITOR
Applicant
FITNESS QUEST, INC.
1375 RAFF RD. S.W.
CANTON,  OH  44750
Applicant Contact DREW H SEVERS
Correspondent
FITNESS QUEST, INC.
1375 RAFF RD. S.W.
CANTON,  OH  44750
Correspondent Contact DREW H SEVERS
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received10/16/1991
Decision Date 01/31/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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