FDA 510(k) Application Details - K202372

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

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510(K) Number K202372
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Conmo Electronic Company Limited
Room 1402, Building No.10,Shenzhen Biomedicine Innovations
Industrial Park, Jinhui Road No.14,Kengzi Street, Pingshan D
Shenzhen City 518126 CN
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Contact Alice Qi
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 08/19/2020
Decision Date 12/30/2020
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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