K043138 is an FDA 510(k) clearance for the PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on November 22, 2004, 10 days after receiving the submission on November 12, 2004.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K043138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2004 |
| Decision Date | November 22, 2004 |
| Days to Decision | 10 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |