The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn 11800 Opthalmoscope.
| Device ID | K003376 |
| 510k Number | K003376 |
| Device Name: | WELCH ALLYN 11800 OPTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Colin Wolff |
| Correspondent | Colin Wolff WELCH ALLYN, INC. 4341 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-30 |
| Decision Date | 2001-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094183948 | K003376 | 000 |
| 00732094344028 | K003376 | 000 |
| 00732094339048 | K003376 | 000 |
| 00732094320718 | K003376 | 000 |
| 00732094320732 | K003376 | 000 |
| 00732094233636 | K003376 | 000 |
| 00732094226102 | K003376 | 000 |
| 00732094089219 | K003376 | 000 |
| 00732094089226 | K003376 | 000 |
| 00732094089240 | K003376 | 000 |
| 00732094089264 | K003376 | 000 |
| 00732094155402 | K003376 | 000 |
| 00732094344011 | K003376 | 000 |