The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio 100 Series System With Confocal Miniprobes.
| Device ID | K150831 |
| 510k Number | K150831 |
| Device Name: | Cellvizio 100 Series System With Confocal Miniprobes |
| Classification | Confocal Optical Imaging |
| Applicant | MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris, FR F-75010 |
| Contact | Sophie Rehault |
| Correspondent | Michael A Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardneville, NV 89460 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-12-22 |
| Summary: | summary |