The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Intra-oral Artificial Larynx.
| Device ID | K831127 |
| 510k Number | K831127 |
| Device Name: | INTRA-ORAL ARTIFICIAL LARYNX |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-06 |
| Decision Date | 1983-07-28 |