K781452 is an FDA 510(k) clearance for the BAYLOW VISUAL ACUITY TESTER. This device is classified as a Chart, Visual Acuity (Class I - General Controls, product code HOX).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 62 days after receiving the submission on August 23, 1978.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1150.
| 510(k) Number | K781452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1978 |
| Decision Date | October 24, 1978 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HOX - Chart, Visual Acuity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1150 |