The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Glaucoma Detector.
| Device ID | K941723 |
| 510k Number | K941723 |
| Device Name: | WELCH ALLYN GLAUCOMA DETECTOR |
| Classification | Perimeter, Ac-powered |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Scott P Gucciardi |
| Correspondent | Scott P Gucciardi WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HOO |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-07 |
| Decision Date | 1994-06-06 |