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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 K102934
Device Name INFRARED EAR THERMOMETER, MODEL IR-04MT
Applicant
Vega Technologies, Inc.
11f-13, 100 Chang-Chun Rd.
Taipei,  TW 104
Applicant Contact JOSEPH LU
Correspondent
Vega Technologies, Inc.
11f-13, 100 Chang-Chun Rd.
Taipei,  TW 104
Correspondent Contact JOSEPH LU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/04/2010
Decision Date 01/14/2011
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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