The following data is part of a premarket notification filed by Optos Plc. with the FDA for P200dtx.
| Device ID | K142897 |
| 510k Number | K142897 |
| Device Name: | P200DTx |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | OPTOS PLC. QUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS Dunfermline, GB Ky11 8gr |
| Contact | Gunhild Paulsen |
| Correspondent | Randy Prebula HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-03 |
| Decision Date | 2015-01-16 |
| Summary: | summary |