Cleared Traditional

K950367 - IV SHUTTLE
(FDA 510(k) Clearance)

K950367 · Equipment Concepts, Inc. · General Hospital

Apr 1995

Decision

85d

Days

Class 1

Risk

K950367 is an FDA 510(k) clearance for the IV SHUTTLE. This device is classified as a Stand, Infusion (Class I - General Controls, product code FOX).

Submitted by Equipment Concepts, Inc. (Phoenix, US). The FDA issued a Cleared decision on April 26, 1995, 85 days after receiving the submission on January 31, 1995.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number	K950367 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 1995
Decision Date	April 26, 1995
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement