LHZ · Viscometer, Mucus, Cervical
Obstetrics/Gynecology · 21 CFR 884.1040 · Class 1
Overview
| Product Code | LHZ |
|---|---|
| Device Name | Viscometer, Mucus, Cervical |
| Regulation | 21 CFR 884.1040 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K936006 | SALTIME VISCOMETER | Harold J. Kosasky, M.D. | Feb 9, 1996 | SESE |
Top Applicants
- Harold J. Kosasky, M.D. — 1 clearance
