KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM

System, X-ray, Extraoral Source, Digital

TROPHY

The following data is part of a premarket notification filed by Trophy with the FDA for Kodak Rvg 6500 System And Kodak Rvg 6500 Ips System.

Pre-market Notification Details

Device IDK093478
510k NumberK093478
Device Name:KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg,  FR 77435
ContactMarie-pierre Labat-camy
CorrespondentMarie-pierre Labat-camy
TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg,  FR 77435
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-09
Decision Date2010-04-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192155008061 K093478 000
60192155008054 K093478 000
60192155008047 K093478 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.