The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Model #12000 Binocular Inderect Ophthalmoscope.
| Device ID | K930023 |
| 510k Number | K930023 |
| Device Name: | MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, 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 | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-05 |
| Decision Date | 1993-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094088908 | K930023 | 000 |
| 00732094087727 | K930023 | 000 |
| 00732094201437 | K930023 | 000 |
| 00732094201444 | K930023 | 000 |
| 00732094018776 | K930023 | 000 |
| 00732094170658 | K930023 | 000 |
| 00732094170726 | K930023 | 000 |
| 00732094222111 | K930023 | 000 |
| 00732094238150 | K930023 | 000 |
| 00732094018677 | K930023 | 000 |
| 00732094018684 | K930023 | 000 |
| 00732094018691 | K930023 | 000 |
| 00732094014006 | K930023 | 000 |
| 00732094018738 | K930023 | 000 |
| 00732094018745 | K930023 | 000 |
| 00732094018783 | K930023 | 000 |
| 00732094018790 | K930023 | 000 |
| 00732094018813 | K930023 | 000 |
| 00732094086515 | K930023 | 000 |