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510(k) K200975

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum by Huntleigh Healthcare Limited — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2020
Date Received
April 13, 2020
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 Huntleigh Healthcare Limited

  • K201425 — Disposable Intraoperative Probe (DIOP8) (February 19, 2021)
  • K132650 — SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM (February 7, 2014)

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)
  • K173941 — IntelliSpace Perinatal Rev.K.00 (September 10, 2018)