The following data is part of a premarket notification filed by Optos Plc with the FDA for Optos Limited Panoramic 200caf.
| Device ID | K100644 |
| 510k Number | K100644 |
| Device Name: | OPTOS LIMITED PANORAMIC 200CAF |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-07-15 |
| Summary: | summary |