PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134— 510(k) K043138

Name: FDA 510(k) clearance K043138
Creator: U.S. Food and Drug Administration
Published: 2004-11-22

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K043138 for PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134, Substantially Equivalent on 2004-11-22. Applicant: Atos Medical AB. Device class: 2.

Clearance details

Applicant: Atos Medical AB
Product code: Code EWL
Device class: Class 2
Regulation: 21 CFR 874.3730
Advisory panel: Ear, Nose, Throat
Date received: 2004-11-12
Decision date: 2004-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Horby, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.