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FDA 510(k)

FERTELL MALE FERTILITY TEST

K-Number: K041039 · 2004-07-20

ApplicantGenosis , Ltd.
Decision Date2004-07-20
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FERTELL MALE FERTILITY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genosis , Ltd.. It received FDA 510(k) clearance on 2004-07-20 under 510(k) number K041039. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERTELL MALE FERTILITY TEST?

FERTELL MALE FERTILITY TEST is a medical device that received FDA 510(k) clearance on 2004-07-20. The listed applicant is Genosis , Ltd.. The 510(k) number is K041039.

When did FERTELL MALE FERTILITY TEST receive FDA 510(k) clearance?

FERTELL MALE FERTILITY TEST received FDA 510(k) clearance on 2004-07-20, under 510(k) number K041039.

Who is the listed applicant for FERTELL MALE FERTILITY TEST?

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

What is the FDA product code for FERTELL MALE FERTILITY TEST?

The FDA product code for FERTELL MALE FERTILITY TEST is POV.

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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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