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510(k) Data Aggregation
K Number
K083233Device Name
THE PFT FILTER
Manufacturer
Date Cleared
2009-03-02
(119 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
PULMONARY FILTRATION TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.
Device Description
The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.
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