FKI · Class II · 21 CFR 876.5820

FDA Product Code FKI: Set, Dialyzer Holder

Leading manufacturers include Extracorporeal Medical Specialities, Inc. and American Bentley.

3
Total
3
Cleared
28d
Avg days
1980
Since

FDA 510(k) Cleared Set, Dialyzer Holder Devices (Product Code FKI)

3 devices
1–3 of 3
Cleared Oct 18, 1984
AMER. BENTLEY HEMOFILTER HOLDER HFH-1
K843504
American Bentley
Gastroenterology & Urology · 42d
Cleared Jun 02, 1981
PARALLEL PLATE DIALYZER HOLDER
K811292
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 22d

About Product Code FKI - Regulatory Context