Cleared Traditional

FRESENIUS DRY ACID DISSOLUTION UNITS

K131611 · Fresenius Medical Care North America · Gastroenterology & Urology
Aug 2013
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K131611 is an FDA 510(k) clearance for the FRESENIUS DRY ACID DISSOLUTION UNITS, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on August 29, 2013, 87 days after receiving the submission on June 3, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K131611 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date August 29, 2013
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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