FDA 510(k) Application Details - K102934

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K102934
Device Name Thermometer, Electronic, Clinical
Applicant VEGA TECHNOLOGIES, INC.
11F-13, 100 CHANG-CHUN RD.
TAIPEI 104 TW
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Contact JOSEPH LU
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/04/2010
Decision Date 01/14/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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