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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