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KMG — Purifier, Water, Ultraviolet, Medical Class II

FDA Device Classification

FDA product code KMG covers "Purifier, Water, Ultraviolet, Medical", a Class II medical device regulated under 21 CFR 880.6710. Submissions are reviewed by the General Hospital panel. At least 9 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KMG
Device Class
Class II
Regulation Number
880.6710
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K012029apolloREMEDY MODEL 2Z12December 31, 2001
K832288mallinckrodt critical careHEMOGLOBINOMETERSeptember 1, 1983
K831253sherwood medicalLANCER HEMOGLOBIN ANALYZER REAGENTSMay 9, 1983
K813048cooper-hewitt electricAQUANOMICS, #MP2SFDecember 2, 1981
K813047cooper-hewitt electricAQUANOMICS, MINI 60LDecember 2, 1981
K813045cooper-hewitt electricAQUANOMICS, #SP36SFDecember 2, 1981
K813049cooper-hewitt electricAQUANOMICS, #HHU100December 2, 1981
K813046cooper-hewitt electricAQUANOMICS, #HHU60December 2, 1981
K813050cooper-hewitt electricAQUANOMICS, #MP4SFDecember 2, 1981

FDA data resources