FDA 510(k) Application Details - K140582

Device Classification Name Oximeter

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510(K) Number K140582
Device Name Oximeter
Applicant SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG 518000 CN
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Contact FIELD FU
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 03/06/2014
Decision Date 08/28/2014
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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