Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THE PFT FILTER

K-Number: K083233 · 2009-03-02

ApplicantPulmonary Filtration Technologies, LLC
Decision Date2009-03-02
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE PFT FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonary Filtration Technologies, LLC. It received FDA 510(k) clearance on 2009-03-02 under 510(k) number K083233. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PFT FILTER?

THE PFT FILTER is a medical device that received FDA 510(k) clearance on 2009-03-02. The listed applicant is Pulmonary Filtration Technologies, LLC. The 510(k) number is K083233.

When did THE PFT FILTER receive FDA 510(k) clearance?

THE PFT FILTER received FDA 510(k) clearance on 2009-03-02, under 510(k) number K083233.

Who is the listed applicant for THE PFT FILTER?

The FDA 510(k) record lists Pulmonary Filtration Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE PFT FILTER?

The FDA product code for THE PFT FILTER is BZG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑