[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.1615]

[Page 519-520]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890_PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart B_Physical Medicine Diagnostic Devices
 
Sec. 890.1615  Miniature pressure transducer.

    (a) Identification. A miniature pressure transducer is a device 
intended for medical purposes to measure the pressure between a device 
and soft tissue by converting mechanical inputs to analog electrical 
signals.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 520]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]