K854118 is an FDA 510(k) clearance for the DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 17, 1986, 159 days after receiving the submission on October 9, 1985.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K854118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1985 |
| Decision Date | March 17, 1986 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |