FDA 510(k) Application Details - K223812

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K223812
Device Name Computer, Diagnostic, Programmable
Applicant Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern, PA 19355 US
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Contact Patricia D Jones
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Regulation Number 870.1425

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Classification Product Code DQK
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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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