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510(k) K233440

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) by Philips Medizin Systeme Boeblingen GmbH — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2024
Date Received
October 18, 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 Philips Medizin Systeme Boeblingen GmbH

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  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866 (December 19, 2023)
  • K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X (November 22, 2023)
  • K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866 (August 22, 2023)
  • K210906 — IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4 (October 7, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K192137 — IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 (September 11, 2020)
  • K182979 — IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue (November 19, 2019)
  • K190624 — EarlyVue VS30 (October 27, 2019)

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