[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.2500]

[Page 280]
 
                        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 C--Monitoring Devices
 
Sec. 868.2500  Cutaneous oxygen monitor.

    (a) Cutaneous oxygen monitor for an infant patient who is not under 
gas anesthesia--(1) Identification. A cutaneous oxygen monitor for an 
infant patient who is not under gas anesthesia is a device that uses a 
noninvasive sensor (e.g., a Clark-type polarographic electrode) placed 
on the patient's skin and that is intended to monitor relative changes 
in the cutaneous oxygen tension in an infant patient who is not under 
gas anesthesia.
    (2) Classification. Class II (performance standards).
    (b) Cutaneous oxygen monitor for all other uses--(1) Identification. 
A cutaneous oxygen monitor for all other uses is a device that uses a 
noninvasive sensor (e.g., a Clark-type polarographic electrode) placed 
on the patient's skin and that is intended to monitor relative changes 
in the cutaneous oxygen tension in a noninfant patient or in any 
patient, including an infant, who is under gas anesthesia.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device described in paragraph (b)(1). See Sec. 868.3.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]