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510(k) K140535

PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 by Philips Medizin Systeme Boblingen GmbH — Product Code HGM

K140535 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50". The FDA issued a decision of Substantially Equivalent on November 25, 2014. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Philips Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2014
Date Received
March 4, 2014
Clearance Type
Abbreviated
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 Boblingen GmbH

  • K151736 — Philips IntelliVue GuardianSoftware (October 21, 2015)
  • K113657 — INTELLIVUE PATIENT MONITOR (March 22, 2012)
  • K102958 — PHILIPS AVALON FETAL MONITOR (March 18, 2011)
  • K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, M (October 21, 2010)
  • K090360 — PHILIPS M3001A MULTI MEASUREMENT SERVER (May 4, 2009)
  • K083228 — PHILIPS INTELLIVUE MP5 PATIENT MONITOR (November 24, 2008)
  • K060541 — THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITO (March 24, 2006)
  • K042845 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONI (November 12, 2004)
  • K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE (October 10, 2003)
  • K031481 — THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 (May 29, 2003)

Other clearances for product code HGM

  • K254036 — Novii+ Wireless Patch System (August 10, 2026)
  • 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)

FDA data resources