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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 K083419
Device Name ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020
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 Received11/19/2008
Decision Date 07/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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