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 ID: K220800
• 510k Number: K220800
• Device Name: Venue Go
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa, WI 53226
• Contact: Lee Bush
• Correspondent: Lee Bush; GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa, WI 53226
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-18
• Decision Date: 2022-06-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278516541	K220800	000
00195278516510	K220800	000