SALTIME VISCOMETER

• K Number: K936006
• Device Name: SALTIME VISCOMETER
• Manufacturer: HAROLD J. KOSASKY, M.D.
• Date Cleared: 1996-02-09 ( 786 days)
• Product Code: LHZ
• Regulation Number: 884.1040

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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