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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 K093795
Device Name ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
Applicant
Actherm, Inc.
6f, #18 Jhanye 2nd Rd.,
Hsinchu Science Park
Hsinchu,  TW 30078
Applicant Contact RICHARD HSIEH
Correspondent
Actherm, Inc.
6f, #18 Jhanye 2nd Rd.,
Hsinchu Science Park
Hsinchu,  TW 30078
Correspondent Contact RICHARD HSIEH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/10/2009
Decision Date 03/12/2010
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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