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

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.

Clearance details

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

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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.