Cleared Traditional

K945993 - VAPOFIL
(FDA 510(k) Clearance)

K945993 · Southmedic, Inc. · Anesthesiology

Feb 1995

Decision

96d

Days

Class 2

Risk

K945993 is an FDA 510(k) clearance for the VAPOFIL, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Southmedic, Inc. (Barrie, Ontario Canada, CA). The FDA issued a Cleared decision on February 22, 1995, 96 days after receiving the submission on November 18, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number	K945993 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1994
Decision Date	February 22, 1995
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement