The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Bi-otoscope.
| Device ID | K955043 |
| 510k Number | K955043 |
| Device Name: | WELCH ALLYN BI-OTOSCOPE |
| Classification | Otoscope |
| 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 | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-03 |
| Decision Date | 1995-11-14 |