Cleared Traditional

K893597 - HYDRAULIC IV POLE
(FDA 510(k) Clearance)

K893597 · Arthro-Medic, Inc. · General Hospital
Oct 1989
Decision
154d
Days
Class 1
Risk

K893597 is an FDA 510(k) clearance for the HYDRAULIC IV POLE, a Stand, Infusion (Class I — General Controls, product code FOX), submitted by Arthro-Medic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 10, 1989, 154 days after receiving the submission on May 9, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number K893597 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1989
Decision Date October 10, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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