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FDA 510(k)

OVU-TRAC OVULATION TIMING KIT

K-Number: K870528 · 1987-05-06

ApplicantOb/Gyn Concepts, Ltd.
Decision Date1987-05-06
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

OVU-TRAC OVULATION TIMING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ob/Gyn Concepts, Ltd.. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K870528. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVU-TRAC OVULATION TIMING KIT?

OVU-TRAC OVULATION TIMING KIT is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Ob/Gyn Concepts, Ltd.. The 510(k) number is K870528.

When did OVU-TRAC OVULATION TIMING KIT receive FDA 510(k) clearance?

OVU-TRAC OVULATION TIMING KIT received FDA 510(k) clearance on 1987-05-06, under 510(k) number K870528.

Who is the listed applicant for OVU-TRAC OVULATION TIMING KIT?

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

What is the FDA product code for OVU-TRAC OVULATION TIMING KIT?

The FDA product code for OVU-TRAC OVULATION TIMING KIT is LHD.

Related Clinical Trials

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Other records listing Ob/Gyn Concepts, Ltd. as applicant

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.

K863610THE OB-GYN CONCEPTS VAGINAL ASPIRATOR

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 AGK122337OVUSENSEFertility Focus, Ltd.K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., Inc.

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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