BLAISE-RATHAEL VOICE PROSTHESIS— 510(k) K832852

Name: FDA 510(k) clearance K832852
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K832852 for BLAISE-RATHAEL VOICE PROSTHESIS, Substantially Equivalent on 1983-09-29. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code EWL
Device class: Class 2
Regulation: 21 CFR 874.3730
Advisory panel: Ear, Nose, Throat
Date received: 1983-08-16
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.