The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan 230.
| Device ID | K212035 |
| 510k Number | K212035 |
| Device Name: | FibroScan 230 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662264001222 | K212035 | 000 |