FDA 510(k) Application Details - K141362

Device Classification Name Oximeter

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510(K) Number K141362
Device Name Oximeter
Applicant CONTEC MEDICAL SYSTEMS CO., LTD.
P.O. BOX 120-119
SHANGAI 200120 CN
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Contact Diana Hong
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 05/23/2014
Decision Date 04/23/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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