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510(k) K021978

PETIT SOPHIA by Nishitomo Co., Inc. — Product Code LHD

K021978 is an FDA 510(k) premarket notification submitted by Nishitomo Co., Inc. for the device "PETIT SOPHIA". The FDA issued a decision of Substantially Equivalent on April 8, 2003. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Nishitomo Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2003
Date Received
June 17, 2002
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 Nishitomo Co., Inc.

  • K901512 — L SOPHIA (July 20, 1990)

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)
  • 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)
  • K901512 — L SOPHIA (July 20, 1990)

FDA data resources