THE PFT FILTER— 510(k) K083233

Name: FDA 510(k) clearance K083233
Creator: U.S. Food and Drug Administration
Published: 2009-03-02

Substantially Equivalent

Pulmonary Filtration Technologies, LLC

FDA 510(k) clearance K083233 for THE PFT FILTER, Substantially Equivalent on 2009-03-02. Applicant: Pulmonary Filtration Technologies, LLC. Device class: 2.

Clearance details

Applicant: Pulmonary Filtration Technologies, LLC
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2008-11-03
Decision date: 2009-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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