FibroScan® Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 630)

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan® Family Of Products (models: 502 Touch, 530 Compact, 430 Mini+, And 630).

Pre-market Notification Details

• Device ID: K203273
• 510k Number: K203273
• Device Name: FibroScan® Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 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: 2020-11-06
• Decision Date: 2021-03-25