FDA 510(k) Application Details - K073454

Device Classification Name Oximeter

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510(K) Number K073454
Device Name Oximeter
Applicant CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI 20030 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 12/10/2007
Decision Date 05/05/2008
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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