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510(k) K110612

FM20 by Mediana Co., Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2011
Date Received
March 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Mediana Co., Ltd.

  • K200434 — V20, V20a, AVSM3 SNF (October 9, 2020)
  • K170497 — V10 (December 15, 2017)
  • K160358 — DT-100 (February 24, 2017)
  • K152659 — V10 (August 25, 2016)
  • K112190 — PATIENT MONITOR (November 9, 2011)
  • K110630 — F10 (June 24, 2011)
  • K100225 — PULSE OXIMETER MODEL P10 (February 9, 2011)
  • K100217 — LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 (June 8, 2010)
  • K051375 — VITAL SIGNS MONITOR (July 28, 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)