Cleared Traditional

DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS

K973051 · Draeger Medical, Inc. · Anesthesiology
Oct 1997
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K973051 is an FDA 510(k) clearance for the DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on October 30, 1997, 76 days after receiving the submission on August 15, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K973051 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1997
Decision Date October 30, 1997
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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