Cleared Traditional

K923265 - FUNNEL ADAPTOR (FDA 510(k) Clearance)

Mar 1993
Decision
259d
Days
Class 2
Risk

K923265 is an FDA 510(k) clearance for the FUNNEL ADAPTOR. This device is classified as 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 March 18, 1993, 259 days after receiving the submission on July 2, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K923265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date March 18, 1993
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAD - Vaporizer, Anesthesia, Non-heated
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5880