The following data is part of a premarket notification filed by Expertech Assoc., Inc. with the FDA for Technomed C-scan Color Ellipsoid Topometer.
| Device ID | K945382 |
| 510k Number | K945382 |
| Device Name: | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER |
| Classification | Keratoscope, Ac-powered |
| Applicant | EXPERTECH ASSOC., INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | David M Link |
| Correspondent | David M Link EXPERTECH ASSOC., INC. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1995-01-31 |