FDA.reportPublic FDA data

510(k) K973860

Device
OVULON MONITOR
Applicant
CONCEPTION TECHNOLOGY, INC.
510(k) number
K973860
Product code
NGE  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-07
Date received
1997-10-09
Regulation
862.1485
Classification name
Test, Luteinizing Hormone (lh), Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TERRY R KNAPP, MD
Address
214 S. College Ave. Ft. Collins CO US 80524 80524

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NGE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020808FERTILITE OVPheromone Sciences Corp.2002-09-23
K990223MODIFICATION OF CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1999-02-24
K981207CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1998-10-28
K863121PEAK OVULATION PREDICTORMicron Technology, Inc.1986-10-14
K850579CUE FERTILITY MONITORZetek, Inc.1985-03-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases