THE GRONINGEN VOICE PROSTHESIS— 510(k) K853940

Substantially Equivalent

Hood Laboratories

FDA 510(k) clearance K853940 for THE GRONINGEN VOICE PROSTHESIS, Substantially Equivalent on 1985-12-13. Applicant: Hood Laboratories.

Clearance details

Applicant: Hood Laboratories
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1985-09-24
Decision date: 1985-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

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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.