FDA 510(k) Application Details - K182495

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K182495
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Shenzhen Jumper Medical Equipment Co., Ltd.
D Building, No. 71, Xintian Road, Fuyong Street, Baoan
District
Shenzhen 518103 CN
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Contact Jinhui Tang
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/11/2018
Decision Date 03/03/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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