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510(k) K122337

OVUSENSE by Fertility Focus, Ltd. — Product Code LHD

K122337 is an FDA 510(k) premarket notification submitted by Fertility Focus, Ltd. for the device "OVUSENSE". The FDA issued a decision of Substantially Equivalent on August 6, 2013. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2013
Date Received
August 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fertility Diagnostic, Proceptive
Device Class
Class U
Regulation Number
Review Panel
OB
Submission Type

Other clearances for product code LHD

  • K200163 — Ava Fertility Tracker (January 19, 2021)
  • K102499 — DUOFERTILITY (December 20, 2011)
  • K050094 — LADY COMP USA (April 20, 2006)
  • K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (September 12, 2003)
  • K021978 — PETIT SOPHIA (April 8, 2003)
  • K002726 — TCOYF FERTILITY SOFTWARE VERSION 1.0 (April 6, 2001)
  • K952756 — MEDI-AID BASAL THERMOMETER (September 25, 1995)
  • K945427 — B-D DIGITAL THERMOMETER (June 15, 1995)
  • K904211 — BIOSELF 2000 FERTILITY INDICATOR (October 14, 1992)
  • K901512 — L SOPHIA (July 20, 1990)

FDA data resources