The following data is part of a premarket notification filed by Optos Plc with the FDA for P200txe.
| Device ID | K190732 |
| 510k Number | K190732 |
| Device Name: | P200TxE |
| Classification | Tomography, Optical Coherence |
| Applicant | Optos Plc Queensferry House, Carnegie Campus, Enterprise Way Dunfermline, GB Ky11 8gr |
| Contact | Rachel Reay |
| Correspondent | Rachel Reay Optos Plc Queensferry House, Carnegie Campus, Enterprise Way Dunfermline, GB Ky11 8gr |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-21 |
| Decision Date | 2019-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05057056107509 | K190732 | 000 |