The following data is part of a premarket notification filed by Mauna Kea Technologies Inc. with the FDA for Cellvizio 100 Series System With Confocal Miniprobes.
| Device ID | K111047 |
| 510k Number | K111047 |
| Device Name: | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES |
| Classification | Confocal Optical Imaging |
| Applicant | MAUNA KEA TECHNOLOGIES INC. 660 NEWTOWN-YARDLEY RD. SUITE 107 Newton, PA 18940 |
| Contact | Chris Tihansky |
| Correspondent | Michael S Ogunleye TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2011-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002472716 | K111047 | 000 |
| 00827002472693 | K111047 | 000 |