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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 K041516
Device Name DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
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 Received06/04/2004
Decision Date 09/08/2004
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
Recalls CDRH Recalls
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