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FDA 510(k) Application Details - K202943
Device Classification Name
Transducer, Pressure, Catheter Tip
More FDA Info for this Device
510(K) Number
K202943
Device Name
Transducer, Pressure, Catheter Tip
Applicant
Opsens Inc.
750 boulevard Du Parc Technologique
Quebec G1P 4S3 CA
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Contact
Marc Chaunet
Other 510(k) Applications for this Contact
Regulation Number
870.2870
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Classification Product Code
DXO
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More FDA Info for this Product Code
Date Received
09/30/2020
Decision Date
11/24/2020
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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