FibroScan

System, Imaging, Pulsed Echo, Ultrasonic

Echosens

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

Pre-market Notification Details

• Device ID: K150239
• 510k Number: K150239
• Device Name: FibroScan
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: Echosens 30 Place D'Italia Paris, FR 75013
• Contact: Celine Fournier
• 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: 2015-02-02
• Decision Date: 2015-09-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03662264000065	K150239	000