Cleared Traditional

WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

K991437 · Wells Johnson Co. · General Hospital
Aug 1999
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K991437 is an FDA 510(k) clearance for the WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on August 30, 1999, 126 days after receiving the submission on April 26, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K991437 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1999
Decision Date August 30, 1999
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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