The following data is part of a premarket notification filed by Optos Plc with the FDA for P200t.
| Device ID | K111628 |
| 510k Number | K111628 |
| Device Name: | P200T |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | OPTOS PLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein OPTOS PLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-10 |
| Decision Date | 2011-08-19 |
| Summary: | summary |