Vscan Air

Transducer, Ultrasonic, Diagnostic

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 Vscan Air.

Pre-market Notification Details

• Device ID: K202035
• 510k Number: K202035
• Device Name: Vscan Air
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnostics, Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226
• Contact: Tracey Ortiz
• Correspondent: Tracey Ortiz; GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 Innovation Drive Wauwatosa, WI 53226
• Product Code: ITX
• Subsequent Product Code: IYN
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-23
• Decision Date: 2020-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682147484	K202035	000
00840682147101	K202035	000
00840682147071	K202035	000