CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 868—ANESTHESIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§868.1030 to §868.1975) > 868.1900—Diagnostic pulmonary-function interpretation calculator.

868.1900—Diagnostic pulmonary-function interpretation calculator.

(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).