SOMATOM EMOTION 16

System, X-ray, Tomography, Computed

SIEMENS MEDICAL SOLUTION, INC. USA

The following data is part of a premarket notification filed by Siemens Medical Solution, Inc. Usa with the FDA for Somatom Emotion 16.

Pre-market Notification Details

Device IDK050297
510k NumberK050297
Device Name:SOMATOM EMOTION 16
ClassificationSystem, X-ray, Tomography, Computed
Applicant SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern,  PA  19355
ContactDebra Peacock
CorrespondentDebra Peacock
SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern,  PA  19355
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-07
Decision Date2005-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056869013114 K050297 000
04056869010304 K050297 000

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