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FDA 510(k) Application Details - K201114
Device Classification Name
Flowmeter, Blood, Cardiovascular
More FDA Info for this Device
510(K) Number
K201114
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
Koven Technology, Inc.
477 N. Lindbergh Blvd., Ste.220
St. Louis, MO 63141 US
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Contact
Heather Bell
Other 510(k) Applications for this Contact
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
04/27/2020
Decision Date
01/05/2021
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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