The following data is part of a premarket notification filed by Cisko Systems with the FDA for Electro-palate.
| Device ID | K840892 |
| 510k Number | K840892 |
| Device Name: | ELECTRO-PALATE |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | CISKO SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-05-22 |