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510(k) Data Aggregation
K Number
K050094Device Name
LADY COMP USA
Manufacturer
LADY COMP USA
Date Cleared
2006-04-20
(461 days)
Product Code
LHD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LADY COMP USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Device Description
Lady-Comp® USA is a computerized basal body temperature thermometer with the following functions:
1) Alarm clock function for measuring temperature at a consistent time.
2) Measuring accuracy within +/- 0.05°C (0.09°F).
3) Displaying the measured temperature.
4) Generating the measurement completion signal.
5) Memory Capacity of data for 180 days.
6) Transferring the stored data to an external instrument.
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