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FDA 510(k)

OVUSENSE

K-Number: K122337 · 2013-08-06

ApplicantFertility Focus, Ltd.
Decision Date2013-08-06
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

OVUSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Fertility Focus, Ltd.. It received FDA 510(k) clearance on 2013-08-06 under 510(k) number K122337. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVUSENSE?

OVUSENSE is a medical device that received FDA 510(k) clearance on 2013-08-06. The listed applicant is Fertility Focus, Ltd.. The 510(k) number is K122337.

When did OVUSENSE receive FDA 510(k) clearance?

OVUSENSE received FDA 510(k) clearance on 2013-08-06, under 510(k) number K122337.

Who is the listed applicant for OVUSENSE?

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

What is the FDA product code for OVUSENSE?

The FDA product code for OVUSENSE is LHD.

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Related Devices (Code: LHD)

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.

K200163Ava Fertility TrackerAva AGK102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., Inc.K002726TCOYF FERTILITY SOFTWARE VERSION 1.0Ovusoft, LLC

Official Source

View on FDA Database →

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

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