FDA 510(k) Application Details - K170965

Device Classification Name Oximeter

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510(K) Number K170965
Device Name Oximeter
Applicant Shenzhen Jumper Medical Equipment Co., Ltd.
Jumper Building, No.71-4, Xintian Avenue, Fuyong Street
Baoan District, Shenzhen 518103 CN
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Contact Yang Gang
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 03/31/2017
Decision Date 11/03/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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