The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio 100 Series With System Confocal Miniprobes.
| Device ID | K141358 |
| 510k Number | K141358 |
| Device Name: | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES |
| Classification | Confocal Optical Imaging |
| Applicant | MAUNA KEA TECHNOLOGIES 340 Jones Lane Gardnerville, NV 89460 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel MAUNA KEA TECHNOLOGIES 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 | 2014-05-23 |
| Decision Date | 2014-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002472754 | K141358 | 000 |