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510(k) K231964

Novii+ Wireless Patch System by Datex Ohmeda — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2023
Date Received
July 3, 2023
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 Datex Ohmeda

  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K213551 — Giraffe Omnibed Carestation CS1 (March 2, 2022)

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)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)
  • K173941 — IntelliSpace Perinatal Rev.K.00 (September 10, 2018)