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FDA 510(k) Application Details - K220106
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K220106
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Qardio Inc
345 California Street, Suite 600 & 700
San Francisco, CA 94104 US
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Contact
Rosario Iannella
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Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
01/12/2022
Decision Date
06/15/2022
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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