LUNG FLUTE— 510(k) K060439

Substantially Equivalent

Medical Acoustics, LLC

FDA 510(k) clearance K060439 for LUNG FLUTE, Substantially Equivalent on 2006-06-22. Applicant: Medical Acoustics, LLC.

Clearance details

Applicant: Medical Acoustics, LLC
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2006-02-21
Decision date: 2006-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.