FDA 510(k) Application Details - K212385

Device Classification Name Oximeter

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510(K) Number K212385
Device Name Oximeter
Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park
Danyang 212300 CN
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Contact Yuzhuo Wang
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/02/2021
Decision Date 08/16/2022
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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