Home / 510(k) Clearances / K091572

510(k) K091572

DISPOSABLE SPO2 SENSOR M1134A by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2009
Date Received
June 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (August 17, 2011)

Other clearances for product code DQA

  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (April 14, 2026)
  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)