The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cellvizio 100 Series And Cellvizio Systems With Confocal Miniprobes.
| Device ID | K122042 |
| 510k Number | K122042 |
| Device Name: | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES |
| Classification | Confocal Optical Imaging |
| Applicant | MAUNA KEA TECHNOLOGIES 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael Daniel |
| Correspondent | Michael Daniel MAUNA KEA TECHNOLOGIES 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-12 |
| Decision Date | 2012-09-04 |
| Summary: | summary |