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 Accessory.
| Device ID | K143678 |
| 510k Number | K143678 |
| Device Name: | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | NINEPOINT MEDICAL, INC. ONE KENDALL SQUARE, SUITE B7501 Cambridge, MA 02139 |
| Contact | Scott Blood |
| Correspondent | Scott Blood NINEPOINT MEDICAL, INC. ONE KENDALL SQUARE, SUITE B7501 Cambridge, MA 02139 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859591006232 | K143678 | 000 |
| 00859591006034 | K143678 | 000 |
| 00859591006041 | K143678 | 000 |
| 00859591006089 | K143678 | 000 |
| 00859591006096 | K143678 | 000 |
| 00859591006157 | K143678 | 000 |
| 00859591006164 | K143678 | 000 |
| 00859591006171 | K143678 | 000 |
| 00859591006188 | K143678 | 000 |
| 00859591006195 | K143678 | 000 |
| 00859591006201 | K143678 | 000 |
| 00859591006027 | K143678 | 000 |