The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Professional Indirect Ophthalmoscope.
| Device ID | K912397 |
| 510k Number | K912397 |
| Device Name: | PROFESSIONAL INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Contact | Michael J Wilkinson |
| Correspondent | Michael J Wilkinson CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY HARLOW, ESSEX CM20 2ED England, GB |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-10-23 |