Cleared Traditional

IMPACT 901 SERIES PORT-A-WALL

K850671 · Impact Instrumentation, Inc. · General Hospital
Mar 1985
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K850671 is an FDA 510(k) clearance for the IMPACT 901 SERIES PORT-A-WALL, a Stand, Infusion (Class I — General Controls, product code FOX), submitted by Impact Instrumentation, Inc. (Bogota, US). The FDA issued a Cleared decision on March 11, 1985, 19 days after receiving the submission on February 20, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number K850671 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 1985
Decision Date March 11, 1985
Days to Decision 19 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