MULTIX Impact C

System, X-ray, Stationary

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Multix Impact C.

Pre-market Notification Details

Device IDK203340
510k NumberK203340
Device Name:MULTIX Impact C
ClassificationSystem, X-ray, Stationary
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern,  PA  19355
ContactMartin Rajchel
CorrespondentMartin Rajchel
Siemens Medical Solutions USA, Inc. 40 Liberty Blvd Mail Code: 65-1A Malvern,  PA  19355
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-01-06

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