ArtUs

System, Imaging, Pulsed Doppler, Ultrasonic

Telemed

The following data is part of a premarket notification filed by Telemed with the FDA for Artus.

Pre-market Notification Details

• Device ID: K211248
• 510k Number: K211248
• Device Name: ArtUs
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: Telemed Highway Business Centre Savanoriu Pr. 178A Vilnius, LT Lt-03154
• Contact: Yury Sokolov
• Correspondent: Yury Sokolov; Telemed Highway Business Centre Savanoriu Pr. 178A Vilnius, LT Lt-03154
• 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: 2021-04-26
• Decision Date: 2022-02-11