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FDA 510(k) Application Details - K211294
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K211294
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
Vyaire Medical, Inc.
26125 North Riverwoods Blvd.
Mettawa, IL 60045 US
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Contact
Joshua Davis
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Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
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More FDA Info for this Product Code
Date Received
04/28/2021
Decision Date
08/16/2021
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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