The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio I.v.e. System With Confocal Miniprobes.
| Device ID | K212322 |
| 510k Number | K212322 |
| Device Name: | Cellvizio I.V.E. System With Confocal Miniprobes |
| Classification | Confocal Optical Imaging |
| Applicant | Mauna Kea Technologies 9 Rue D'Enghien Paris, FR 75010 |
| Contact | Aline Criton |
| Correspondent | Michael A. Daniel Daniel & Daniel Consulting 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-07-26 |
| Decision Date | 2021-08-18 |