Cleared Traditional

MD2 PERSONAL INFUSION SYSTEM

K896544 · Norfolk Medical Products, Inc. · General Hospital
May 1990
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K896544 is an FDA 510(k) clearance for the MD2 PERSONAL INFUSION SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on May 2, 1990, 166 days after receiving the submission on November 17, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K896544 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1989
Decision Date May 02, 1990
Days to Decision 166 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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