K941723 is an FDA 510(k) clearance for the WELCH ALLYN GLAUCOMA DETECTOR. This device is classified as a Perimeter, Ac-powered (Class I - General Controls, product code HOO).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 6, 1994, 60 days after receiving the submission on April 7, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K941723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1994 |
| Decision Date | June 06, 1994 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOO — Perimeter, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |