VOICE MASTER PROSTHESIS— 510(k) K974132

Name: FDA 510(k) clearance K974132
Creator: U.S. Food and Drug Administration
Published: 1998-02-25

Substantially Equivalent

E. Benson Hood Lab, Inc.

FDA 510(k) clearance K974132 for VOICE MASTER PROSTHESIS, Substantially Equivalent on 1998-02-25. Applicant: E. Benson Hood Lab, Inc.. Device class: 2.

Clearance details

Applicant: E. Benson Hood Lab, Inc.
Product code: Code EWL
Device class: Class 2
Regulation: 21 CFR 874.3730
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-03
Decision date: 1998-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

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.