Cleared Special

MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

K040847 · Draeger Medical, Inc. · Anesthesiology
Jun 2004
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K040847 is an FDA 510(k) clearance for the MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on June 17, 2004, 77 days after receiving the submission on April 1, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K040847 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2004
Decision Date June 17, 2004
Days to Decision 77 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

Similar Devices — CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 303
Medical Gas Analyzer (AG200)
K250148 · Prior Care Science Technology, Ltd. · Aug 2025
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
K243956 · Nihon Kohden Corporation · Jun 2025
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
K251216 · Barbaras Development, Inc. · Jun 2025
AIM (N/A)
K240937 · Inventeur, LLC · Dec 2024
AirLife? Open Et Oxygen Mask, AirLife? Open Et+ Oxygen Mask
K230915 · Vyaire Medical, Inc. · Nov 2024
MicroTrend System
K212425 · Exostat Medical, Inc. · Nov 2024