Cleared Traditional

K921168 - ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
(FDA 510(k) Clearance)

K921168 · Allen Medical Systems, Inc. · General Hospital

Apr 1993

Decision

407d

Days

Class 1

Risk

K921168 is an FDA 510(k) clearance for the ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000. This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).

Submitted by Allen Medical Systems, Inc. (Bedford Heights, US). The FDA issued a Cleared decision on April 21, 1993, 407 days after receiving the submission on March 10, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.

Submission Details

510(k) Number	K921168 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 10, 1992
Decision Date	April 21, 1993
Days to Decision	407 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement