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FDA 510(k)

OVULON MONITOR

K-Number: K973860 · 1998-01-07

ApplicantConception Technology, Inc.
Decision Date1998-01-07
Product CodeNGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVULON MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Conception Technology, Inc.. It received FDA 510(k) clearance on 1998-01-07 under 510(k) number K973860. The device is classified under product code NGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVULON MONITOR?

OVULON MONITOR is a medical device that received FDA 510(k) clearance on 1998-01-07. The listed applicant is Conception Technology, Inc.. The 510(k) number is K973860.

When did OVULON MONITOR receive FDA 510(k) clearance?

OVULON MONITOR received FDA 510(k) clearance on 1998-01-07, under 510(k) number K973860.

Who is the listed applicant for OVULON MONITOR?

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

What is the FDA product code for OVULON MONITOR?

The FDA product code for OVULON MONITOR is NGE.

Related Clinical Trials

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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Other records listing Conception Technology, Inc. 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.

K030117ENHANCE SPERM FREEZEK030116ENHANCE-S PLUS HK991322ENHANCE-S PLUSK991104MICROTOOLS

Related Devices (Code: NGE)

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.

K020808FERTILITE OVPheromone Sciences Corp.K990223MODIFICATION OF CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.K981207CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.K863121PEAK OVULATION PREDICTORMicron Technology, Inc.K850579CUE FERTILITY MONITORZetek, Inc.

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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