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510(k) K200163

Ava Fertility Tracker by Ava AG — Product Code LHD

K200163 is an FDA 510(k) premarket notification submitted by Ava AG for the device "Ava Fertility Tracker". The FDA issued a decision of Substantially Equivalent on January 19, 2021. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2021
Date Received
January 22, 2020
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

  • 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)
  • K901512 — L SOPHIA (July 20, 1990)

FDA data resources