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510(k) K043003

TCM40 MONITORING SYSTEM by Radiometer Medical Aps — Product Code LKD

K043003 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "TCM40 MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 1, 2005. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2005
Date Received
November 1, 2004
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 Radiometer Medical Aps

  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (September 21, 2017)
  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K160153 — ABL90 FLEX PLUS (November 4, 2016)
  • K142898 — ABL800 FLEX with AQURE connectivity (June 17, 2015)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K131988 — ABL90 FLEX ANALYZER (September 17, 2013)
  • K130144 — ABL90 FLEX (July 31, 2013)
  • K123748 — ABL90 FLEX (May 7, 2013)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)

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)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • 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)
  • 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