Cleared Traditional

FUNNEL ADAPTOR

K923265 · Southmedic, Inc. · Anesthesiology
Mar 1993
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K923265 is an FDA 510(k) clearance for the FUNNEL ADAPTOR, 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 review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K923265 FDA.gov
FDA Decision Cleared 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

Similar Devices — CAD Vaporizer, Anesthesia, Non-heated

All 56
V80 Anesthetic Vaporizer (V80)
K240375 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2024
Tec 820, Tec 850
K172702 · Datex-Ohmeda, Inc. · Jan 2018
V60 Anesthetic Vaporizer
K150167 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015
SEVOFLURANE VAPORIZER ADAPTOR
K110608 · Piramal Critcal Care, Inc (Formerly Minrad, Inc) · Jul 2011
SIGMA ALPHA VAPORIZER
K060331 · Penlon Limited · May 2006
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K053564 · Penlon Limited · Mar 2006