The following data is part of a premarket notification filed by Ninepoint Medical, Inc. with the FDA for Nvisionvle Imaging System, Nvisionvle Optical Probe, Nvisionvle Inflation System.
| Device ID | K182616 |
| 510k Number | K182616 |
| Device Name: | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System |
| 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 | 2018-09-21 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859591006270 | K182616 | 000 |
| 00859591006263 | K182616 | 000 |