Cleared Traditional

DK*300 VOLUMETRIC INFUSION CONTROLLER

K843254 · Deka Research & Development Corp. · General Hospital
Oct 1984
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K843254 is an FDA 510(k) clearance for the DK*300 VOLUMETRIC INFUSION CONTROLLER, a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR), submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on October 11, 1984, 52 days after receiving the submission on August 20, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K843254 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1984
Decision Date October 11, 1984
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LDR — Controller, Infusion, Intravascular, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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