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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thermometer, electronic, clinical
510(k) Number K881909
Device Name TOSHIBA DIGITAL CLINICAL THERMOMETER
Applicant
TOSHIBA GLASS CO., LTD.
MORI BLDG. SHIMBASHI ANNEX 2F
35-10,SHIM. 5-CHOME. MINATO-KU
TOKYO, 105 JAPAN,  JP
Applicant Contact MASAAKI HOSHINO
Correspondent
TOSHIBA GLASS CO., LTD.
MORI BLDG. SHIMBASHI ANNEX 2F
35-10,SHIM. 5-CHOME. MINATO-KU
TOKYO, 105 JAPAN,  JP
Correspondent Contact MASAAKI HOSHINO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/06/1988
Decision Date 05/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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