The following data is part of a premarket notification filed by Ninepoint Medical, Inc. with the FDA for Nvision Vle Imaging System.
| Device ID | K120800 |
| 510k Number | K120800 |
| Device Name: | NVISION VLE IMAGING SYSTEM |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | NINEPOINT MEDICAL, INC. 1171 BARROILHET AVE Hillsborough, CA 94010 |
| Contact | Cindy Domecus, Rac (us & Eu) |
| Correspondent | Cindy Domecus, Rac (us & Eu) NINEPOINT MEDICAL, INC. 1171 BARROILHET AVE Hillsborough, CA 94010 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2013-04-25 |
| Summary: | summary |