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510(k) K843699

BIOSELF TM 110 by Bioself, Inc. — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
September 20, 1984
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.

  • K904211 — BIOSELF 2000 FERTILITY INDICATOR (October 14, 1992)
  • 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)
  • K904211 — BIOSELF 2000 FERTILITY INDICATOR (October 14, 1992)