PART 868 -- ANESTHESIOLOGY DEVICES
Subpart B--Diagnostic Devices
(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
(b) Classification. Class II (performance standards).
The information on this page is current as of April 1 2015.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
Page Last Updated: 08/21/2015
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