FibroScan® 630

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan® 630.

Pre-market Notification Details

• Device ID: K200655
• 510k Number: K200655
• Device Name: FibroScan® 630
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: Echosens 6 Rue Ferrus Paris, FR 75014
• Contact: Karine Bonenfant
• Correspondent: Zvi Ladin; Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 Dedham, MA 02026
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-12
• Decision Date: 2020-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03662264001161	K200655	000