K940638 is an FDA 510(k) clearance for the PROVOX(TM) VOICE PROSTHESIS. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Atos Medical AB (Horby, Sweden, SE). The FDA issued a Cleared decision on June 22, 1994, 128 days after receiving the submission on February 14, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K940638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1994 |
| Decision Date | June 22, 1994 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |