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FDA 510(k) Application Details - K223843
Device Classification Name
Flowmeter, Blood, Cardiovascular
More FDA Info for this Device
510(K) Number
K223843
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
Flosonics Medical
325 Front St W, Floor 4
Toronto M5V 2Y1 CA
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Contact
Caleb Chin
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Regulation Number
870.2100
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Classification Product Code
DPW
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More FDA Info for this Product Code
Date Received
12/22/2022
Decision Date
05/03/2023
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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