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KXM — System Accessories, Extracorporeal Class II

FDA Device Classification

Classification Details

Product Code
KXM
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K925581baxter healthcareBAXTER BIOSTAT 1000 UREA MONITORMay 3, 1995
K863471colorado medicalCOLORADO MEDICAL MODEL PTC 1000October 2, 1986
K853536cp medicalVELCRO FISTULA PRESSURE CLAMPSOctober 17, 1985
K831402parker hannifinPRESSURE MONITOR & CONTROL UNIT APC-02AAugust 8, 1983