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510(k) K880618

FERTILITY FORECASTER COMPUTER PROGRAM by Fertile Time, Ltd. — Product Code LHD

K880618 is an FDA 510(k) premarket notification submitted by Fertile Time, Ltd. for the device "FERTILITY FORECASTER COMPUTER PROGRAM". The FDA issued a decision of Substantially Equivalent on June 24, 1988. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1988
Date Received
February 16, 1988
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)
  • K122337 — OVUSENSE (August 6, 2013)
  • 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)

FDA data resources