Accuro

System, Imaging, Pulsed Echo, Ultrasonic

Rivanna Medical, LLC

The following data is part of a premarket notification filed by Rivanna Medical, Llc with the FDA for Accuro.

Pre-market Notification Details

• Device ID: K171594
• 510k Number: K171594
• Device Name: Accuro
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: Rivanna Medical, LLC 107 E Water St Charlottesville, VA 22902
• Contact: William Mauldin
• Correspondent: William Mauldin; Rivanna Medical, LLC 107 E Water St Charlottesville, VA 22902
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-31
• Decision Date: 2017-10-20
• Summary: summary