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510(k) K904211

BIOSELF 2000 FERTILITY INDICATOR by Bioself, Inc. — Product Code LHD

K904211 is an FDA 510(k) premarket notification submitted by Bioself, Inc. for the device "BIOSELF 2000 FERTILITY INDICATOR". The FDA issued a decision of Substantially Equivalent on October 14, 1992. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Bioself, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
September 12, 1990
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 by Bioself, Inc.

  • K843699 — BIOSELF TM 110 (December 4, 1984)
  • K823209 — BIOSELF 101 (February 15, 1983)

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

FDA data resources