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510(k) Data Aggregation
K Number
K043148Device Name
ALL FLOW PULMONARY FUNCTION FILTER
Manufacturer
ALLIANCE TECH MEDICAL, INC.
Date Cleared
2004-12-13
(28 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE TECH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.
Device Description
The All Flow Pulmonary Function Filter, manufactured by Alliance Tech Medical, Inc., is a see barrier type, bi-directional filter fabricated from a plastic resin that is a filtering medium. The customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.
The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from a white opaque of miller the and the machine housings are fabricated from the same plastic but with different colors. The colored end fits the machine and the white opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.
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