The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Audioscope 3 Model 23300 Accessories.
| Device ID | K884218 |
| 510k Number | K884218 |
| Device Name: | AUDIOSCOPE 3 MODEL 23300 ACCESSORIES |
| Classification | Audiometer |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Watkins |
| Correspondent | John Watkins WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1989-03-10 |