COMPACT TOUCH

System, Imaging, Pulsed Echo, Ultrasonic

QUANTEL S.A.

The following data is part of a premarket notification filed by Quantel S.a. with the FDA for Compact Touch.

Pre-market Notification Details

• Device ID: K094038
• 510k Number: K094038
• Device Name: COMPACT TOUCH
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: QUANTEL S.A. 601 HAGGERTY LANE Bozeman, MT 59715
• Contact: Mike Johnson
• Correspondent: Mike Johnson; QUANTEL S.A. 601 HAGGERTY LANE Bozeman, MT 59715
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-30
• Decision Date: 2010-04-22
• Summary: summary