FDA 510(k) Application Details - K051269

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K051269
Device Name Thermometer, Electronic, Clinical
Applicant RADIANT INNOVATION INC.
1F, NO. 3 INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK,
HSIN CHU TW
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Contact FRANK LIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/17/2005
Decision Date 09/09/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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