Search Results
Found 1 results
510(k) Data Aggregation
K Number
K021978Device Name
PETIT SOPHIA
Manufacturer
NISHITOMO CO., INC.
Date Cleared
2003-04-08
(295 days)
Product Code
LHD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NISHITOMO CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
Device Description
This device is the clinical thermometer with memory the following functions.
(1) Alarm clock function for measuring temperature at constant time.
(2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C)
(3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened.
(4) Memory capacity of data for 6 menstrual cycles or 210 days.
(5) Displaying the measured temperature value in graph.
(6) Transferring the stored data to an external instrument.
Ask a Question
Page 1 of 1