Venue Go

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 Venue Go.

Pre-market Notification Details

Device IDK202233
510k NumberK202233
Device Name:Venue Go
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 Received2020-08-07
Decision Date2020-11-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682190503 K202233 000
00195278005861 K202233 000
00840682190299 K202233 000

Trademark Results [Venue Go]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENUE GO
VENUE GO
87321949 5840113 Live/Registered
General Electric Company
2017-02-02

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