The following data is part of a premarket notification filed by Modulated Imaging, Inc. with the FDA for Clarifi Imaging System.
| Device ID | K181623 |
| 510k Number | K181623 |
| Device Name: | Clarifi Imaging System |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Modulated Imaging, Inc. 17151 Gillette Ave Irvine, CA 92604 |
| Contact | David Cuccia |
| Correspondent | Maureen O'connell O’Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-20 |
| Decision Date | 2018-07-19 |
| Summary: | summary |