FDA 510(k) Application Details - K092549

Device Classification Name Oximeter

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510(K) Number K092549
Device Name Oximeter
Applicant BIO MEDICAL TECHNOLOGIES CO., LTD
5536 TROWBRIDGE DRIVE
DUNWOODY, GA 30338 US
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Contact CATHRYN CAMBRIA
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/19/2009
Decision Date 11/16/2009
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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