(51 days)
The Viasys MASTERSCREEN CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The MASTERSCREEN CPX system allows the monitoring of metabolic parameters. The MASTERSCREEN CPX system is intended to use with adults and children over the age of 14 years.
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This document is a letter from the FDA to Viasys Healthcare GmbH regarding the clearance of their device, the MasterScreen CPX. It primarily focuses on the regulatory clearance process and does not contain detailed information about acceptance criteria or specific study results showing device performance.
Therefore, I cannot extract the requested information from the provided text. The document confirms the device's substantial equivalence to a predicate device but does not include the technical performance study details that would typically define acceptance criteria and prove their fulfillment.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).