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This document is a determination from the FDA regarding the substantial equivalence of the Alerkan Spirometry Filters to predicate devices, indicating that the device can be marketed under specific
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How to fill out Alerkan Spirometry Filters Substantial Equivalence Determination
01
Obtain the Alerkan Spirometry Filters Substantial Equivalence Determination form.
02
Read the instructions carefully to understand the requirements.
03
Gather necessary information about the device, including its specifications.
04
Identify and categorize the intended use of the device.
05
Compile data comparing the Alerkan Spirometry Filters to a predicate device, highlighting similarities and differences.
06
Document any testing data and results that support the equivalence claim.
07
Review all sections of the form to ensure completeness and accuracy.
08
Submit the completed form along with any required supporting documents to the appropriate regulatory body.
Who needs Alerkan Spirometry Filters Substantial Equivalence Determination?
01
Manufacturers of medical devices seeking approval for Alerkan Spirometry Filters.
02
Companies wanting to demonstrate substantial equivalence to existing spirometry filters.
03
Regulatory compliance teams within medical device companies.
04
Healthcare providers needing to understand the approval process for new devices.
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People Also Ask about
What does a spirometry test tell you?
Normal findings of spirometry are an FEV1/FVC ratio of greater than 0.70 and both FEV1 and FVC above 80% of the predicted value. If lung volumes are performed, TLC above 80% of the predictive value is normal. Diffusion capacity above 75% of the predicted value is also considered normal.
What is spirometry filter?
Spirometry is the most common of the lung function tests, measuring lung function, in particular, the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. GVS provides Filters for Lung Function Testing (Spiroguard) with proven filtration of 99,9999% up to 0,027 micron.
What is spirometry test in English?
Spirometry (spy-ROM-uh-tree) is a common test used to check how well your lungs work. It measures how much air you breathe in, how much you breathe out and how quickly you breathe out.
What happens if you fail a spirometry test?
The most common type of PFT, this test measures the amount of air you can breathe out or exhale and how fast you can empty air from the lungs. Spirometry is used to diagnose lung diseases that affect the airways, like COPD or asthma. Lung volume testing measures the amount of air your lungs can hold.
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What is Alerkan Spirometry Filters Substantial Equivalence Determination?
Alerkan Spirometry Filters Substantial Equivalence Determination is a regulatory process by which a manufacturer demonstrates that their spirometry filters are substantially equivalent to a legally marketed device in terms of safety and effectiveness.
Who is required to file Alerkan Spirometry Filters Substantial Equivalence Determination?
Manufacturers of Alerkan Spirometry Filters or similar devices who intend to market their products in the U.S. must file for Substantial Equivalence Determination to the FDA.
How to fill out Alerkan Spirometry Filters Substantial Equivalence Determination?
To fill out the Alerkan Spirometry Filters Substantial Equivalence Determination, manufacturers must provide detailed information on the device's specifications, intended use, safety and effectiveness data, and comparison to a predicate device.
What is the purpose of Alerkan Spirometry Filters Substantial Equivalence Determination?
The purpose of this determination is to ensure that new spirometry filters are safe for use and perform as intended, while allowing manufacturers to bring their products to market efficiently.
What information must be reported on Alerkan Spirometry Filters Substantial Equivalence Determination?
The information that must be reported includes device descriptions, indications for use, preclinical and clinical data, labeling, and a comparison to the predicate device highlighting similarities and differences.
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