CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000

Camera, Scintillation (gamma)

INTER MEDICAL MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Inter Medical Medizintechnik Gmbh with the FDA for Cx 250 C Plus With Gammaxp Software, Model 0121 0000.

Pre-market Notification Details

Device IDK052473
510k NumberK052473
Device Name:CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
ClassificationCamera, Scintillation (gamma)
Applicant INTER MEDICAL MEDIZINTECHNIK GMBH DAIMLERSTRASSE 34-36 Luebbecke,  DE D-32312
ContactHans Guenter Osiek
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-09-09
Decision Date2005-10-28

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