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FDA 510(k) Application Details - K223812
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K223812
Device Name
Computer, Diagnostic, Programmable
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern, PA 19355 US
Other 510(k) Applications for this Company
Contact
Patricia D Jones
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
12/20/2022
Decision Date
09/15/2023
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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