The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Video Ophthalmoscope.
| Device ID | K951210 |
| 510k Number | K951210 |
| Device Name: | WELCH ALLYN VIDEO OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | WELCH ALLYN, INC. 4341 SOUTH STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Craig Mullin |
| Correspondent | Craig Mullin WELCH ALLYN, INC. 4341 SOUTH STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-17 |
| Decision Date | 1995-06-06 |