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510(k) K111083

PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code HGM

K111083 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50". The FDA issued a decision of Substantially Equivalent on August 17, 2011. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2011
Date Received
April 19, 2011
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 Medizinsysteme Boeblingen GmbH, Cardiac AN

  • K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE P (May 19, 2014)
  • K132320 — INTELLIVUE CL RESPIRATION POD (March 26, 2014)
  • K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 (October 17, 2013)
  • K131829 — INTELLIVUE PATIENT MONITOR (August 16, 2013)
  • K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (June 14, 2013)
  • K120366 — INTELLIVUE PATIENT MONITOR (July 18, 2012)
  • K113441 — PHYSIOLOGICAL MONITOR, PATIENT MONITOR (March 22, 2012)
  • K111905 — INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, (October 4, 2011)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • K110622 — INTELLIVUE PATIENT MONITOR (March 31, 2011)

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)

FDA data resources