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FDA 510(k) Application Details - K230884
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K230884
Device Name
Computer, Diagnostic, Programmable
Applicant
Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311 US
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Contact
Kevin Catalano
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
03/30/2023
Decision Date
09/26/2023
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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