FDA 510(k) Application Details - K212300

Device Classification Name Oximeter

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510(K) Number K212300
Device Name Oximeter
Applicant Shenzhen Mericonn Technology Co., Ltd.
Room 20203, Building 6, Donglongxing Kejiyuan, Huaning Road
Xinshishequ, Dalang Street
Shenzhen 518109 CN
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Contact Jiang Chuanyuan
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/22/2021
Decision Date 02/25/2022
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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