STRAIT'MAP OPTION

System, X-ray, Angiographic

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Strait'map Option.

Pre-market Notification Details

Device IDK973368
510k NumberK973368
Device Name:STRAIT'MAP OPTION
ClassificationSystem, X-ray, Angiographic
Applicant GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-08
Decision Date1997-10-17
Summary:summary

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