Home / 510(k) Clearances / K844043

510(k) K844043

OVUDATE by Joel R.L. Ehren Kranz — Product Code LHD

K844043 is an FDA 510(k) premarket notification submitted by Joel R.L. Ehren Kranz for the device "OVUDATE". The FDA issued a decision of Substantially Equivalent on February 15, 1985. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Joel R.L. Ehren Kranz has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1985
Date Received
October 17, 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 Joel R.L. Ehren Kranz

  • K853515 — PEE WEE THERMOMETERS (October 16, 1985)

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