The following data is part of a premarket notification filed by Fluoptics with the FDA for Fluobeam Lx.
| Device ID | K190891 |
| 510k Number | K190891 |
| Device Name: | Fluobeam LX |
| Classification | Parathyroid Autofluorescence Imaging Device |
| Applicant | Fluoptics 7 Parvis Louis Neel, CS 20050 Grenoble Cedex 9, FR |
| Contact | Odile Allard |
| Correspondent | Michael A. Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | QDG |
| CFR Regulation Number | 878.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-04-05 |
| Decision Date | 2019-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B475FBLX0 | K190891 | 000 |
| B475FBLM0 | K190891 | 000 |