The following data is part of a premarket notification filed by Optos Plc with the FDA for Panoramic, Model 200ma.
| Device ID | K060424 |
| 510k Number | K060424 |
| Device Name: | PANORAMIC, MODEL 200MA |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | OPTOS PLC 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein OPTOS PLC 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-17 |
| Decision Date | 2006-03-17 |
| Summary: | summary |