FDA 510(k) Application Details - K202934

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

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510(K) Number K202934
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone
No. 5 Baolong Road
Shenzhen 518116 CN
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Contact Yiqing Feng
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/29/2020
Decision Date 01/26/2021
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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