The following data is part of a premarket notification filed by Optina Diagnostics with the FDA for Mydriatic Hyperspectral Retinal Camera (mhrc-c1).
| Device ID | K200254 |
| 510k Number | K200254 |
| Device Name: | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Optina Diagnostics 7405 Route Transcanadienne, Suite 300 Montreal, CA H4t 1z2 |
| Contact | Jean-philippe Sylvestre |
| Correspondent | Elisa Harvey CardioMed Device Consultants LLC 1783 Forest Drive, #254 Annapolis, MD 21401 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627987702125 | K200254 | 000 |