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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K881670
Device Name ACCUTEMP PLUS
Applicant
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Applicant Contact DAVID SHERATON
Correspondent
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Correspondent Contact DAVID SHERATON
Regulation Number880.5130
Classification Product Code
FMT  
Date Received04/18/1988
Decision Date 11/22/1988
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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