The following data is part of a premarket notification filed by Ultravoice, Ltd. with the FDA for American Artificial Larynx.
| Device ID | K914816 |
| 510k Number | K914816 |
| Device Name: | AMERICAN ARTIFICIAL LARYNX |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | ULTRAVOICE, LTD. 19 EAST CENTRAL AVE. Paoli, PA 19301 |
| Contact | David R Baraff |
| Correspondent | David R Baraff ULTRAVOICE, LTD. 19 EAST CENTRAL AVE. Paoli, PA 19301 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-25 |
| Decision Date | 1993-02-12 |