Venue Fit

System, Imaging, Pulsed Doppler, Ultrasonic

GE Medical Systems

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Venue Fit.

Pre-market Notification Details

• Device ID: K220848
• 510k Number: K220848
• Device Name: Venue Fit
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnoistics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226
• Contact: Lee Bush
• Correspondent: Lee Bush; GE Medical Systems Ultrasound And Primary Care Diagnoistics, 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: 2022-03-23
• Decision Date: 2022-06-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278516497	K220848	000
00195278513014	K220848	000