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DTY — Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DTY
Device Class
Class II
Regulation Number
870.4410
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093650medtronicBIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMFebruary 17, 2010
K963698international biophysicsCM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4March 20, 1997
K954501medtronic bio-medicusBIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMJanuary 16, 1996
K9026543m health careCDI (TM) SYSTEM 100 MONITORING SYSTEMNovember 5, 1990
K900860cardio metricsPERFUSION MONITORAugust 14, 1990
K864703cardiovascular devicesMODIFIED GAS-STAT(TM) MONITORING SYSTEMFebruary 19, 1987
K840749cardiovascular devicesGAST STAT MONITORING SYSTEMApril 17, 1984
K822000cardiovascular devicesEXTRACORPOREAL BLOOD GAS SYSTEMDecember 22, 1982