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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 K955142
Device Name DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A
Applicant
Salutron, Inc.
629 Park Hill Rd.
Danville,  CA  94526
Applicant Contact LOWELL CROW
Correspondent
Salutron, Inc.
629 Park Hill Rd.
Danville,  CA  94526
Correspondent Contact LOWELL CROW
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/13/1995
Decision Date 12/29/1995
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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