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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 K852903
Device Name TOSHIBA DIGITAL CLINICAL THERMOMTER
Applicant
TOSHIBA MEDICAL SYSTEMS
TOKYO OFFICE MORI BLDG SHINBAS
35-10, SHINBASHI 5-CHOME
MINATO-KU, TOKYO, 105, JA,  JP
Applicant Contact HOSHINO
Correspondent
TOSHIBA MEDICAL SYSTEMS
TOKYO OFFICE MORI BLDG SHINBAS
35-10, SHINBASHI 5-CHOME
MINATO-KU, TOKYO, 105, JA,  JP
Correspondent Contact HOSHINO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/09/1985
Decision Date 07/24/1985
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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