Cleared Traditional

UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

K872652 · Travenol Laboratories, S.A. · Gastroenterology & Urology
Sep 1987
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K872652 is an FDA 510(k) clearance for the UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM, a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on September 30, 1987, 85 days after receiving the submission on July 7, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K872652 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1987
Decision Date September 30, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FKX — System, Peritoneal, Automatic Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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