FDA 510(k) Application Details - K232520

Device Classification Name Oximeter

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510(K) Number K232520
Device Name Oximeter
Applicant Shenzhen Smallsignal Technology Co., Ltd.
Room 901-7,Building 1, No.9, Jinxiu Middle Road,
Laokeng Community, Longtian Street, Pingshan
Shenzhen 518122 CN
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Contact Qingliang Liu
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/18/2023
Decision Date 11/21/2024
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 K232520


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