The following data is part of a premarket notification filed by Optos Plc with the FDA for Panoramic 200a.
| Device ID | K042001 |
| 510k Number | K042001 |
| Device Name: | PANORAMIC 200A |
| Classification | Ophthalmoscope, Ac-powered |
| 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 | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-10-07 |
| Summary: | summary |