The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Ophthalmoscope, Model #11100.
| Device ID | K770768 |
| 510k Number | K770768 |
| Device Name: | OPHTHALMOSCOPE, MODEL #11100 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | WELCH ALLYN, INC. Skaneateles Falls Skaneateles, NY 13153 |
| Contact | Richard W. Newman |
| Correspondent | Richard W. Newman WELCH ALLYN, INC. Skaneateles Falls Skaneateles, NY 13153 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-04-28 |
| Decision Date | 1977-05-06 |