Cleared Traditional

UNICOR, INC. VENTILATOR HOSES

K953785 · Unicor, Inc. · Anesthesiology

Sep 1995

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K953785 is an FDA 510(k) clearance for the UNICOR, INC. VENTILATOR HOSES, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Unicor, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 18, 1995, 35 days after receiving the submission on August 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K953785 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 1995
Decision Date	September 18, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement