Cleared Traditional

MILLIPORE DUAL RATE INTRAVENOUS CASSETTE

K811432 · Millipore Corp. · General Hospital
Jul 1981
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K811432 is an FDA 510(k) clearance for the MILLIPORE DUAL RATE INTRAVENOUS CASSETTE, a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR), submitted by Millipore Corp. (Walker, US). The FDA issued a Cleared decision on July 13, 1981, 52 days after receiving the submission on May 22, 1981. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K811432 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1981
Decision Date July 13, 1981
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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