Product Code: LHZ FDA class 1 21 CFR 884.1040

Viscometer, Mucus, Cervical

Obstetrics/Gynecology

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.

510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K936006 SALTIME VISCOMETER