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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 K090031
Device Name ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
Applicant
ACTHERM, INC.
6F, NO.18 JHANYE 2ND RD.,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Applicant Contact RICHARD HSIEH
Correspondent
ACTHERM, INC.
6F, NO.18 JHANYE 2ND RD.,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Correspondent Contact RICHARD HSIEH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/05/2009
Decision Date 04/16/2009
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
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