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 | K150949 |
| 510k Number | K150949 |
| Device Name: | FibroScan |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ECHOSENS 30 PLACE D'ITALIE Paris, FR 75013 |
| Contact | Celine Fournier |
| Correspondent | Zvi Ladin BOSTON MEDTECH ADVISORS INC. 990 WASHINGTON ST 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 | 2015-04-08 |
| Decision Date | 2015-06-03 |
| Summary: | summary |
Trademark Results [FibroScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBROSCAN 79094348 4072585 Live/Registered |
ECHOSENS 2011-01-27 |
 FIBROSCAN 79016519 3209344 Live/Registered |
ECHOSENS 2005-08-25 |
 FIBROSCAN 74721757 not registered Dead/Abandoned |
Immunomedics, Inc. 1995-08-28 |
 FIBROSCAN 74214670 not registered Dead/Abandoned |
IMMUNOMEDICS, INC. 1991-10-23 |
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