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FDA 510(k)

GENUA MENOPAUSE MONITOR TEST KIT

K-Number: K002450 · 2001-01-12

ApplicantGenua 1944, Inc.
Decision Date2001-01-12
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENUA MENOPAUSE MONITOR TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genua 1944, Inc.. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K002450. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENUA MENOPAUSE MONITOR TEST KIT?

GENUA MENOPAUSE MONITOR TEST KIT is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Genua 1944, Inc.. The 510(k) number is K002450.

When did GENUA MENOPAUSE MONITOR TEST KIT receive FDA 510(k) clearance?

GENUA MENOPAUSE MONITOR TEST KIT received FDA 510(k) clearance on 2001-01-12, under 510(k) number K002450.

Who is the listed applicant for GENUA MENOPAUSE MONITOR TEST KIT?

The FDA 510(k) record lists Genua 1944, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENUA MENOPAUSE MONITOR TEST KIT?

The FDA product code for GENUA MENOPAUSE MONITOR TEST KIT is CGJ.

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Related Devices (Code: CGJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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