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510(k) Data Aggregation
(158 days)
BODY BOX 5500
The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.
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This document is a 510(k) clearance letter from the FDA for the "Body Box 5500" device. It does not contain the specific information needed to answer the request about acceptance criteria and a study proving a device meets them. The letter confirms substantial equivalence to a predicate device but does not detail performance metrics, study design, or results.
Therefore, I cannot provide the requested information based on the provided text.
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