FDA 510(k) Application Details - K202324

Device Classification Name Oximeter

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510(K) Number K202324
Device Name Oximeter
Applicant Shenzhen BSX Technology Electronics Co., Ltd.
Rm301.3F 8th Building, LiHao Industrial Area,
No.78 AiNan Road, Longgang
Shenzhen 518116 CN
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Contact Fang Kai
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/17/2020
Decision Date 12/14/2020
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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