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510(k) Data Aggregation
K Number
K142303Device Name
NeumoFilt Ergo/Neumo Filt BiteOn
Manufacturer
Date Cleared
2014-11-20
(94 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
Medical Respiratory Devices S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient's exhaled air and the testing equipment. Single patient use, disposable. Duraton of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices.
Device Description
The MRD NeumoFilt pulmonary function filter ("PFT filter") is a standard electrostatic filter that is placed between the patient and the pulmonary function testing equipment to keep a patient inhaled and exhaled breath from contaminating the equipment. There are 2 models with the only difference being the patient end piece which is either a biteblock shape (BiteOn) or the mouthpiece shape (Ergo).
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