Cleared Special

K020485 - ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML (FDA 510(k) Clearance)

K020485 · Baxter Healthcare Corp · General Hospital

Mar 2002

Decision

27d

Days

Class 2

Risk

K020485 is an FDA 510(k) clearance for the ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 12, 2002, 27 days after receiving the submission on February 13, 2002.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number	K020485 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 2002
Decision Date	March 12, 2002
Days to Decision	27 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF