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KJH — Apparatus, Perfusion Class I

FDA Device Classification

FDA product code KJH covers "Apparatus, Perfusion", a Class I medical device regulated under 21 CFR 864.2240. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KJH
Device Class
Class I
Regulation Number
864.2240
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K875151endotronicsACUSYST-P/3XJanuary 12, 1988
K872086endotronicsACUSYST-JRJune 15, 1987
K864334endotronicsACUSYST-P (CELL CULTURE EQUIPMENT)November 24, 1986

FDA data resources