SALTIME VISCOMETER
Device Facts
| Record ID | K936006 |
|---|---|
| Device Name | SALTIME VISCOMETER |
| Applicant | Harold J. Kosasky, M.D. |
| Product Code | LHZ · Obstetrics/Gynecology |
| Decision Date | Feb 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1040 |
| Device Class | Class 1 |
Regulatory Classification
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.
