Cleared Traditional

K820575 - J.E.T. DIALYSIS SYSTEM
(FDA 510(k) Clearance)

K820575 · Computer Dialysis Systems, Inc. · Gastroenterology & Urology device

May 1982

Decision

78d

Days

Class 2

Risk

K820575 is an FDA 510(k) clearance for the J.E.T. DIALYSIS SYSTEM. This device is classified as a Filter, Blood, Dialysis (Class II - Special Controls, product code FKJ).

Submitted by Computer Dialysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1982, 78 days after receiving the submission on March 3, 1982.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K820575 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 1982
Decision Date	May 20, 1982
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—