SILHOUETTE FC

System, X-ray, Stationary

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Silhouette Fc.

Pre-market Notification Details

Device IDK993090
510k NumberK993090
Device Name:SILHOUETTE FC
ClassificationSystem, X-ray, Stationary
Applicant GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentReiner Krumme
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-09-16
Decision Date1999-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682120777 K993090 000

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