The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan 530 Compact.
| Device ID | K160524 |
| 510k Number | K160524 |
| Device Name: | FibroScan 530 Compact |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ECHOSENS 30 Place D'Italie Paris, FR 75013 |
| 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 | 2016-02-25 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662264001062 | K160524 | 000 |