The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Otoscope.
| Device ID | K950787 |
| 510k Number | K950787 |
| Device Name: | WELCH ALLYN OTOSCOPE |
| Classification | Otoscope |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Craig D Mullin |
| Correspondent | Craig D Mullin 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 | 1995-02-21 |
| Decision Date | 1995-04-06 |