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 ID: K191792
• 510k Number: K191792
• Device Name: Versana Balance
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 W. Innovation Drive Wauwatosa, WI 53226
• Contact: Tracey Ortiz
• Correspondent: Tracey Ortiz; GE Medical Systems Ultrasound And Primary Care Diagnostics 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: 2019-07-03
• Decision Date: 2019-08-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682142618	K191792	000
00840682142595	K191792	000