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510(k) K844043

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

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)

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  • 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)