Product code KJH

Device name: Apparatus, Perfusion
Medical specialty: Hematology
Device class: 1
Regulation number: 864.2240
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: Y
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

Related 510(k) Records

510(k)	Device	Applicant	Decision date
K875151	ACUSYST-P/3X	Endotronics, Inc.	1988-01-12
K872086	ACUSYST-JR	Endotronics, Inc.	1987-06-15
K864334	ACUSYST-P (CELL CULTURE EQUIPMENT)	Endotronics, Inc.	1986-11-24