Cleared Traditional

ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE

K874020 · Abbott Laboratories · Gastroenterology & Urology
Jan 1988
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K874020 is an FDA 510(k) clearance for the ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE, a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II — Special Controls, product code KPF), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 29, 1988, 119 days after receiving the submission on October 2, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K874020 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1987
Decision Date January 29, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KPF — System, Dialysate Delivery, Semi-automatic, Peritoneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630