K944616 is an FDA 510(k) clearance for the KERATRON CORNEAL TOPOGRAPHER. This device is classified as a Keratoscope, Ac-powered (Class I - General Controls, product code HLQ).
Submitted by Alliance Medical Marketinig (Jacksonville Beach, US). The FDA issued a Cleared decision on November 22, 1994, 63 days after receiving the submission on September 20, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1350.
| 510(k) Number | K944616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1994 |
| Decision Date | November 22, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HLQ — Keratoscope, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1350 |