K190732 is an FDA 510(k) clearance for the P200TxE. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on July 31, 2019, 132 days after receiving the submission on March 21, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K190732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |