Cleared Traditional

PORT-A-POLE

K961470 · Prins Medical Ind., Inc. · General Hospital
Jul 1996
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K961470 is an FDA 510(k) clearance for the PORT-A-POLE, a Stand, Infusion (Class I — General Controls, product code FOX), submitted by Prins Medical Ind., Inc. (Ventura, US). The FDA issued a Cleared decision on July 22, 1996, 96 days after receiving the submission on April 17, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number K961470 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1996
Decision Date July 22, 1996
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FOX — Stand, Infusion
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6990