Ovulon Monitor

FDA 510(k) K973860 · Conception Technology, Inc.

Substantially Equivalent

510(k) numberK973860

Submission

Device name
Ovulon Monitor
Applicant
Conception Technology, Inc.
Ft. Collins, CO, US
Received
October 9, 1997
Decision date
January 7, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NGE – Test, Luteinizing Hormone (Lh), Over The Counter
Device class
Class I (low risk)
Regulation
21 CFR 862.1485
Specialty
Clinical Chemistry

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K981207Clearplan Easy Fertility MonitorNGE · Traditional Unipath , Ltd.10/28/1998SE
K863121Peak Ovulation PredictorNGE · Traditional Micron Technology, Inc.10/14/1986SE
K850579Cue Fertility MonitorNGE · Traditional Zetek, Inc.03/22/1985SE

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Questions and answers

When was Ovulon Monitor cleared by the FDA?

Ovulon Monitor (K973860) received a 510(k) decision of Substantially Equivalent on January 7, 1998, 90 days after the submission was received.

What is the product code of K973860?

The FDA product code is NGE – Test, Luteinizing Hormone (Lh), Over The Counter, a Class I (low risk) device regulated under 21 CFR 862.1485.