The following data is part of a premarket notification filed by Mimosa Diagnostics Inc with the FDA for Mimosa Imager.
| Device ID | K190334 |
| 510k Number | K190334 |
| Device Name: | MIMOSA Imager |
| Classification | Oximeter, Tissue Saturation |
| Applicant | MIMOSA Diagnostics Inc 1 Yonge St Suite 201 Toronto, CA M5e1e5 |
| Contact | Yuan Fang |
| Correspondent | Yuan Fang MIMOSA Diagnostics Inc 1 Yonge St Suite 201 Toronto, CA M5e1e5 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627987881806 | K190334 | 000 |