RADIANALYZER XPRESS

Computer, Diagnostic, Programmable

RADI MEDICAL SYSTEMS AB

The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Radianalyzer Xpress.

Pre-market Notification Details

Device IDK092105
510k NumberK092105
Device Name:RADIANALYZER XPRESS
ClassificationComputer, Diagnostic, Programmable
Applicant RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala,  SE Se-754 50
ContactMats Granlund
CorrespondentMats Granlund
RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala,  SE Se-754 50
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-14
Decision Date2009-10-09
Summary:summary

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