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510(k) K845009

RABBIT-PERSONAL COMPUTER FOR WOMEN by Sanimor, Inc. — Product Code LHD

K845009 is an FDA 510(k) premarket notification submitted by Sanimor, Inc. for the device "RABBIT-PERSONAL COMPUTER FOR WOMEN". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
December 26, 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 for product code LHD

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  • 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