FDA.reportPublic FDA data

510(k) K821507

Device
SYMPTOTHERM 8 FERTILITY INDICATOR
Applicant
OVIX CORP., INC.
510(k) number
K821507
Product code
LHD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-14
Date received
1982-05-20
Regulation
510(k) Premarket Notification
Classification name
Device, Fertility Diagnostic, Proceptive
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Obstetrics/Gynecology
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200163Ava Fertility TrackerAva AG2021-01-19
K122337OVUSENSEFertility Focus, Ltd.2013-08-06
K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.2011-12-20
K050094LADY COMP USALady Comp USA2006-04-20
K030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.2003-09-12
K021978PETIT SOPHIANishitomo Co., Inc.2003-04-08
K002726TCOYF FERTILITY SOFTWARE VERSION 1.0Ovusoft, LLC2001-04-06
K952756MEDI-AID BASAL THERMOMETERPolymedica Industries, Inc.1995-09-25
K945427B-D DIGITAL THERMOMETERBd Becton Dickinson Vacutainer Systems Preanalytic1995-06-15
K904211BIOSELF 2000 FERTILITY INDICATORBioself, Inc.1992-10-14
K901512L SOPHIANishitomo Co., Inc.1990-07-20
K880618FERTILITY FORECASTER COMPUTER PROGRAMFertile Time, Ltd.1988-06-24
K870999GENDER CHOICE INFORMATION KIT, FEMALE AND MALEProcare C/O Wiley, Rein & Fielding1987-07-14
K870528OVU-TRAC OVULATION TIMING KITOb/Gyn Concepts, Ltd.1987-05-06
K852194MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMETSharp Electronics Corp.1985-09-27

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