Cleared Traditional

K945193 - ALL-IN-ONE TWO CHAMBER CONTAINER (FDA 510(k) Clearance)

K945193 · Baxter Healthcare Corp · General Hospital

May 1995

Decision

200d

Days

Class 2

Risk

K945193 is an FDA 510(k) clearance for the ALL-IN-ONE TWO CHAMBER CONTAINER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).

Submitted by Baxter Healthcare Corp (Jayuya, US). The FDA issued a Cleared decision on May 12, 1995, 200 days after receiving the submission on October 24, 1994.

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

Submission Details

510(k) Number	K945193 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 24, 1994
Decision Date	May 12, 1995
Days to Decision	200 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF