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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 K031905
Device Name DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
Applicant
Actherm, Inc.
6th F, No 85
Kuan-Min 6 Rd. Jubei 302
Hsinchu,  TW 302
Applicant Contact RICHARD HSIEH
Correspondent
Actherm, Inc.
6th F, No 85
Kuan-Min 6 Rd. Jubei 302
Hsinchu,  TW 302
Correspondent Contact RICHARD HSIEH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/20/2003
Decision Date 07/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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