Viscometer, Mucus, Cervical
A cervical mucus viscometer is an instrument used in obstetrics and gynecology to measure the viscosity and physical properties of cervical mucus, providing information relevant to the assessment of fertility, ovulatory function, and the timing of the fertile period. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It bears product code LHZ and is regulated under 21 CFR 884.1040 within the Obstetrics/Gynecology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LHZ
- Device Class
- FDA class 1
- Regulation Number
- 884.1040
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K936006 | SALTIME VISCOMETER | Feb 09, 1996 | Substantially Equivalent | Harold J. Kosasky, M.D. |