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510(k) K043597

FC 700 FETAL MONITOR by Bionet Co., Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2005
Date Received
December 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type

Other clearances by Bionet Co., Ltd.

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  • K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10 (October 11, 2022)
  • K130322 — SPM-300 (November 15, 2013)
  • K113306 — CARDIO 7 (July 16, 2012)
  • K102767 — CARDIO XP (June 3, 2011)
  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K082008 — BIONET BM3PLUS PATIENT MONITOR (December 11, 2008)
  • K043598 — FC 1400 FETAL MONITOR (December 16, 2005)

Other clearances for product code HGM

  • K253021 — ANNE Maternal (February 26, 2026)
  • K250777 — Sonicaid Team3 (September 19, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K241009 — PeriCALM Patterns 3.0 (January 10, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231964 — Novii+ Wireless Patch System (December 8, 2023)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)