Versana Premier

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems Ultrasound And Primary Care Diagnostics,

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

Pre-market Notification Details

Device IDK210438
510k NumberK210438
Device Name:Versana Premier
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 W Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics, 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 Received2021-02-12
Decision Date2021-09-10

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