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KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Class II

FDA Device Classification

Classification Details

Product Code
KLK
Device Class
Class II
Regulation Number
868.2500
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K003943linde medical sensorsMICROGAS 7650 TRANSCUTANEOUS MONITORMay 4, 2001
K991644linde medical sensorsMICROGAS 7650 TRANSCUTANEOUS MONITORMay 21, 1999
K980287siemens medical solutions usaSIEMENS SC9000/SC9015 TCP02/C02 MODULEAugust 12, 1998
K924709air-shieldsSATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEJanuary 17, 1996
K924679air-shields vickersOXYCARE(TM) OXYGEN CONTROLLER/MONITORFebruary 21, 1995
K925910hewlett-packardHEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEJuly 29, 1993
K893133mennen medicalHORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXXJuly 14, 1989
K870805novametrix medical systemsMODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITORMay 27, 1987
K861861ge medical systems information technologies515A NEO-TRAK NEONATAL MONITORJuly 10, 1986
K860124mennen medicalHORIZON 2000 TRANSCUTANEOUS GAS MONITORINGMay 9, 1986
K860951kontron instrumentsKONTRON CUTANEOUS PO2 MONITOR 820April 9, 1986
K852959sumitomo electric industriesPO-510 TCPO2 MONITORNovember 29, 1985
K851451vulcan laboratoriesSTAT GAS MODULEAugust 2, 1985
K844253novametrix medical systemsNOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2January 10, 1985
K844079novametrix medical systemsNOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGENNovember 30, 1984
K842497litton datamedixSERVOMED OXYMONITO SMK 363October 4, 1984
K842374novametrix medical systemsNOVAMETRIX 850 TRANSCUTANEOUS OXYGENSeptember 17, 1984
K840993novametrix medical systemsTRANSCUTANEOUS 800-OXYGEN MONITORS/801April 24, 1984
K840919creative care systemsDAYPAK SYS VII CATHETER CARE KITApril 17, 1984
K840918biochem internationalMICRO SPAN TRANSCUTANEOUS OXYGEN MONITApril 17, 1984