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510(k) K870528

OVU-TRAC OVULATION TIMING KIT by Ob/Gyn Concepts, Ltd. — Product Code LHD

K870528 is an FDA 510(k) premarket notification submitted by Ob/Gyn Concepts, Ltd. for the device "OVU-TRAC OVULATION TIMING KIT". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Ob/Gyn Concepts, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
February 5, 1987
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 Ob/Gyn Concepts, Ltd.

  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (January 7, 1987)

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