LUNG FLUTE THERAPEUTIC— 510(k) K091557

Substantially Equivalent

Medical Acoustics

FDA 510(k) clearance K091557 for LUNG FLUTE THERAPEUTIC, Substantially Equivalent on 2010-01-04. Applicant: Medical Acoustics. Device class: 2.

Clearance details

Applicant: Medical Acoustics
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2009-05-27
Decision date: 2010-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.