LUNG FLUTE— 510(k) K060439

Name: FDA 510(k) clearance K060439
Creator: U.S. Food and Drug Administration
Published: 2006-06-22

Substantially Equivalent

Medical Acoustics, LLC

FDA 510(k) clearance K060439 for LUNG FLUTE, Substantially Equivalent on 2006-06-22. Applicant: Medical Acoustics, LLC. Device class: 2.

Clearance details

Applicant: Medical Acoustics, LLC
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
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 ↗

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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.