Cleared Traditional

HEMODIALYSIS TUBING SETS

K001971 · Ofi Biomedica S.P.A. · Gastroenterology & Urology
May 2001
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K001971 is an FDA 510(k) clearance for the HEMODIALYSIS TUBING SETS, a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Ofi Biomedica S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on May 24, 2001, 330 days after receiving the submission on June 28, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K001971 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2000
Decision Date May 24, 2001
Days to Decision 330 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FIB — Protector, Transducer, Dialysis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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