FDA 510(k) Applications for Medical Device Product Code "LKD"
(Monitor, Carbon-Dioxide, Cutaneous)

FDA 510(k) Number Applicant Device Name Decision Date
K980756 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE 11/05/1998
K043357 LINDE MEDICAL SENSORS AG TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 03/04/2005
K131253 PERIMED AB PERIFLUX 6000 10/22/2013
K990960 PERIMED, INC. PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) 09/23/1999
K110474 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN PHILIPS INTELLIVUE TCG10 09/30/2011
K093154 RADIOMETER MEDICAL APS TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM 02/05/2010
K043003 RADIOMETER MEDICAL APS TCM40 MONITORING SYSTEM 03/01/2005
K151329 SENTEC AG SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet 12/17/2015
K101690 SENTEC AG SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE 12/03/2010
K041548 SENTEC INC. SENTEC DIGITAL MONITOR MODEL #SDM 08/09/2004


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