FDA 510(k) Applications for Medical Device Product Code "LHD"
(Device, Fertility Diagnostic, Proceptive)

FDA 510(k) Number Applicant Device Name Decision Date
K200163 Ava AG Ava Fertility Tracker 01/19/2021
K102499 CAMBRIDGE TEMPERATURE CONCEPTS LTD. DUOFERTILITY 12/20/2011
K122337 FERTILITY FOCUS LTD OVUSENSE 08/06/2013
K050094 LADY COMP USA LADY COMP USA 04/20/2006
K030961 MICROLIFE CORP. MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 09/12/2003
K021978 NISHITOMO CO., INC. PETIT SOPHIA 04/08/2003
K002726 OVUSOFT, LLC. TCOYF FERTILITY SOFTWARE VERSION 1.0 04/06/2001


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