The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for Eyecap Imaging System.
| Device ID | K000368 |
| 510k Number | K000368 |
| Device Name: | EYECAP IMAGING SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Contact | M.j. Wilkinson |
| Correspondent | M.j. Wilkinson CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-04 |
| Decision Date | 2000-05-04 |