The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio I.v.e. With Confocal Miniprobes.
| Device ID | K193416 |
| 510k Number | K193416 |
| Device Name: | Cellvizio I.V.E. With Confocal Miniprobes |
| Classification | Confocal Optical Imaging |
| Applicant | Mauna Kea Technologies 9 Rue D'Enghien Paris, FR 75010 |
| Contact | Veronique Dentan |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760187912103 | K193416 | 000 |
| 03760187912004 | K193416 | 000 |
| 03760187912011 | K193416 | 000 |
| 03760187912028 | K193416 | 000 |
| 03760187912035 | K193416 | 000 |
| 03760187912042 | K193416 | 000 |
| 03760187912059 | K193416 | 000 |
| 03760187912073 | K193416 | 000 |
| 03760187912080 | K193416 | 000 |
| 03760187912097 | K193416 | 000 |
| 03760187913001 | K193416 | 000 |