FDA.reportPublic FDA data

510(k) K021978

Device
PETIT SOPHIA
Applicant
Nishitomo Co., Inc.
510(k) number
K021978
Product code
LHD
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-08
Date received
2002-06-17
Classification name
Device, Fertility Diagnostic, Proceptive
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LLOYD DUPLANTIS
Address
3696 W. Main St. Gray LA US 70359 70359

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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
K852801BIOCHRON FERTILITY INDICATORFertil-A-Chron, Inc.1985-09-19