The following data is part of a premarket notification filed by Optos Plc with the FDA for Panoramic200 Opthalmoscope.
| Device ID | K983999 |
| 510k Number | K983999 |
| Device Name: | PANORAMIC200 OPTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OPTOS PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein OPTOS PLC 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1999-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05057056010212 | K983999 | 000 |