The following data is part of a premarket notification filed by Ninepoint Medical, Inc with the FDA for Nvisionvle Low-profile Optical Probe.
| Device ID | K191117 |
| 510k Number | K191117 |
| Device Name: | NvisionVLE Low-profile Optical Probe |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | NinePoint Medical, Inc 12 Oak Park Drive Bedford, MA 01730 |
| Contact | Eman Namati |
| Correspondent | Eman Namati NinePoint Medical, Inc 12 Oak Park Drive Bedford, MA 01730 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-26 |
| Decision Date | 2019-07-19 |