Versana Balance

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 Balance.

Pre-market Notification Details

Device IDK220446
510k NumberK220446
Device Name:Versana Balance
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentLee Bush
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 Received2022-02-16
Decision Date2022-05-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278300096 K220446 000
00195278300034 K220446 000

Trademark Results [Versana Balance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSANA BALANCE
VERSANA BALANCE
87925656 not registered Live/Pending
General Electric Company
2018-05-17

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