SOMATOM FORCE

System, X-ray, Tomography, Computed

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 Somatom Force.

Pre-market Notification Details

Device IDK133589
510k NumberK133589
Device Name:SOMATOM FORCE
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactKimberly Mangum
CorrespondentKimberly Mangum
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-22
Decision Date2014-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869006956 K133589 000

Trademark Results [SOMATOM FORCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMATOM FORCE
SOMATOM FORCE
79142144 4570526 Live/Registered
Siemens Healthcare GmbH
2013-11-20

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