[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1900]

[Page 285]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868--ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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).