FDA 510(k) Application Details - K173368

Device Classification Name Oximeter

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510(K) Number K173368
Device Name Oximeter
Applicant Shenzhen Coreray Technology, Ltd.
ChuangYe Technology Park
1th Dong Huan Road, Longhua New District
Shenzhen 518109 CN
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Contact Simon Fan
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/26/2017
Decision Date 08/31/2018
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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