PEGASUS

System, Imaging, Pulsed Doppler, Ultrasonic

ADVANCED TECHNOLOGY LABORATORIES, INC.

The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Pegasus.

Pre-market Notification Details

• Device ID: K935009
• 510k Number: K935009
• Device Name: PEGASUS
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003
• Contact: Terence J Sweeney
• Correspondent: Terence J Sweeney; ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003
• Product Code: IYN
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-20
• Decision Date: 1994-10-11