VUMAX

System, Imaging, Pulsed Echo, Ultrasonic

SONOMED, INC.

The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Vumax.

Pre-market Notification Details

• Device ID: K060626
• 510k Number: K060626
• Device Name: VUMAX
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: SONOMED, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Contact: George Myers
• Correspondent: George Myers; SONOMED, INC. 377 ROUTE 17 S Hasbrouck Heights, NJ 07604
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-09
• Decision Date: 2006-04-11
• Summary: summary