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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K822939
Device Name HEART RATE & TEMP. MEASUREMENT SYSTEM
Applicant
Camino Laboratories, Inc.
Anaheim,  CA 
Correspondent
Camino Laboratories, Inc.
Anaheim,  CA 
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/04/1982
Decision Date 11/24/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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