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 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART B—Obstetrical and Gynecological Diagnostic Devices (§884.1040 to §884.1730) > 884.1040—Viscometer for cervical mucus.

884.1040—Viscometer for cervical mucus.

(a) Identification. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 884.9.

Code of Federal Regulations

[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]