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FDA 510(k) Application Details - K190852
Device Classification Name
Transducer, Pressure, Catheter Tip
More FDA Info for this Device
510(K) Number
K190852
Device Name
Transducer, Pressure, Catheter Tip
Applicant
Zurich Medical Inc.
2405 Xenium Lane N
Plymouth, MN 55441 US
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Contact
Kin-Joe Sham
Other 510(k) Applications for this Contact
Regulation Number
870.2870
More FDA Info for this Regulation Number
Classification Product Code
DXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2019
Decision Date
08/14/2019
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
Y
Expedited Review
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