FDA 510(k) Application Details - K240092

Device Classification Name Oximeter

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510(K) Number K240092
Device Name Oximeter
Applicant Shenzhen Yimi Life Technology Co., Ltd.
302 Building C, YouLiTong Technology Industrial Plant, No.56
Qingsong Road, Laokeng Community, Longtian Street
Shenzhen 518118 CN
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Contact Peng Shande
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 01/12/2024
Decision Date 10/25/2024
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

FDA Source Information for K240092


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