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510(k) Data Aggregation
K Number
K033518Device Name
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
Manufacturer
Date Cleared
2004-03-10
(124 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PLASTIC PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Custom Plastic Products Pulmonary Function Filter is intended to prevent cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
The Custom Plastic Products Pulmonary Function Filter is intended to reduce cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
Device Description
The Custom Plastic Products Pulmonary Function Filter is a disposable barrier type filter intended to prevent contamination cross-contamination when using spirometers and pulmonary function testing instruments. The filter also prevents the transmission of harmful bacteria from the instruments to the patient.
The device consists of a plastic housing with a filtering efficiency greater than The filter is designed for inspiratory and expiratory air flow. 99%.
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