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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 K063291
Device Name INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
Applicant
Choice Smart Health Care Co. , Ltd.
2108 Ciro'S Plaza
388 W. Nanjing Rd.
Shanghai,  CN 200003
Applicant Contact JANICE MA
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/01/2006
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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