BLOM-SINGER LOW PRESSURE VOICE PROSTHES— 510(k) K842896

Substantially Equivalent

American V. Mueller

FDA 510(k) clearance K842896 for BLOM-SINGER LOW PRESSURE VOICE PROSTHES, Substantially Equivalent on 1984-08-17. Applicant: American V. Mueller.

Clearance details

Applicant: American V. Mueller
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1984-07-23
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.