The following data is part of a premarket notification filed by Optimed, Inc. with the FDA for Ect-100 Electronic Corneal Topographer.
| Device ID | K890687 |
| 510k Number | K890687 |
| Device Name: | ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER |
| Classification | Keratoscope, Ac-powered |
| Applicant | OPTIMED, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson OPTIMED, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-09-05 |