FDA 510(k) Application Details - K120502

Device Classification Name Oximeter

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510(K) Number K120502
Device Name Oximeter
Applicant SHENZHEN CREATIVE INDUSTRY CO., LTD
77325 JOYCE WAY
ECHO, OR 97826 US
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Contact CHARLES MACK
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 02/21/2012
Decision Date 12/07/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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