Versana Premier

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems Ultrasound And

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And with the FDA for Versana Premier.

Pre-market Notification Details

Device IDK200138
510k NumberK200138
Device Name:Versana Premier
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-07-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000
00840682146296 K200138 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.