FDA 510(k) Application Details - K202213

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K202213
Device Name System, X-Ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates, IL 60192 US
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Contact Veronica Padharia
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 08/06/2020
Decision Date 10/11/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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