FDA 510(k) Application Details - K081788

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K081788
Device Name Thermometer, Electronic, Clinical
Applicant INNOCHIPS TECHNOLOGY CO., LTD.
49 CANDLEWOOD WAY
BUENA PARK, CA 90621 US
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Contact BRANDON CHOI
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 06/24/2008
Decision Date 12/17/2008
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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