Cleared Traditional

AMICON EQUALINE FLUID BALANCE SYSTEM

K875121 · Amicon, Inc. · Gastroenterology & Urology

Feb 1988

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K875121 is an FDA 510(k) clearance for the AMICON EQUALINE FLUID BALANCE SYSTEM, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on February 19, 1988, 66 days after receiving the submission on December 15, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number	K875121 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 1987
Decision Date	February 19, 1988
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—