K901363 is an FDA 510(k) clearance for the TOPOGRAPHIC MODELING SYSTEM. This device is classified as a Keratoscope, Ac-powered (Class I - General Controls, product code HLQ).
Submitted by Computed Anatomy, Inc. (New York, US). The FDA issued a Cleared decision on May 25, 1990, 63 days after receiving the submission on March 23, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1350.
| 510(k) Number | K901363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1990 |
| Decision Date | May 25, 1990 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLQ — Keratoscope, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1350 |