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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 K070028
Device Name CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
Applicant
Actherm, Inc.
6th F., #85 Kuan-Min 6 Rd.
Jubei, Hsinchu,  TW 302
Applicant Contact RICHARD HSIEH
Correspondent
Actherm, Inc.
6th F., #85 Kuan-Min 6 Rd.
Jubei, Hsinchu,  TW 302
Correspondent Contact RICHARD HSIEH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/03/2007
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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