The following data is part of a premarket notification filed by Optos Plc with the FDA for P200te.
| Device ID | K173707 |
| 510k Number | K173707 |
| Device Name: | P200TE |
| Classification | Tomography, Optical Coherence |
| Applicant | Optos Plc Queensferry House, Carnegie Business Campus, Dunfermline, GB Ky118gr |
| Contact | Geoff Fatzinger |
| Correspondent | Geoff Fatzinger Optos Plc Queensferry House, Carnegie Business Campus, Dunfermline, GB Ky118gr |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-02-28 |
| Summary: | summary |