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510(k) K110474

PHILIPS INTELLIVUE TCG10 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code LKD

K110474 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "PHILIPS INTELLIVUE TCG10". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
February 18, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
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)
  • K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (August 17, 2011)
  • K110622 — INTELLIVUE PATIENT MONITOR (March 31, 2011)

Other clearances for product code LKD

  • K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
  • K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V- (December 17, 2015)
  • K131253 — PERIFLUX 6000 (October 22, 2013)
  • K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR AD (December 3, 2010)
  • K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (February 5, 2010)
  • K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (March 4, 2005)
  • K043003 — TCM40 MONITORING SYSTEM (March 1, 2005)
  • K041548 — SENTEC DIGITAL MONITOR MODEL #SDM (August 9, 2004)
  • K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (September 23, 1999)
  • K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (November 5, 1998)

FDA data resources