The following data is part of a premarket notification filed by Dynamed Audio, Inc. with the FDA for Resnick Emitter, Artificial Larynx.
| Device ID | K854158 |
| 510k Number | K854158 |
| Device Name: | RESNICK EMITTER, ARTIFICIAL LARYNX |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | DYNAMED AUDIO, INC. R.D. 1 BOX 415A Natrona Heights, PA 15065 |
| Contact | Joseph A Resnick |
| Correspondent | Joseph A Resnick DYNAMED AUDIO, INC. R.D. 1 BOX 415A Natrona Heights, PA 15065 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-12-13 |