The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Ophthalmoscope.
| Device ID | K950461 |
| 510k Number | K950461 |
| Device Name: | WELCH ALLYN 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 | 1995-02-03 |
| Decision Date | 1995-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094146080 | K950461 | 000 |
| 00732094016482 | K950461 | 000 |
| 00732094016499 | K950461 | 000 |
| 00732094016611 | K950461 | 000 |
| 00732094016673 | K950461 | 000 |
| 00732094087475 | K950461 | 000 |
| 00732094087499 | K950461 | 000 |
| 00732094089295 | K950461 | 000 |
| 00732094089417 | K950461 | 000 |
| 00732094089431 | K950461 | 000 |
| 00732094103007 | K950461 | 000 |
| 00732094103113 | K950461 | 000 |
| 00732094140163 | K950461 | 000 |
| 00732094016437 | K950461 | 000 |