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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 K874694
Device Name ADAP-TEMP, MODEL: AT-100
Applicant
Respiratory Support Products, Inc.
3118 Alpine
Santa Ana,  CA  92704
Applicant Contact ANTHONY V BERAN
Correspondent
Respiratory Support Products, Inc.
3118 Alpine
Santa Ana,  CA  92704
Correspondent Contact ANTHONY V BERAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/13/1987
Decision Date 03/01/1988
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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