Modification to Vamos Anesthetic Gas Monitor
FDA 510(k) K040847 · Draeger Medical, Inc.
510(k) numberK040847
Submission
- Device name
- Modification to Vamos Anesthetic Gas Monitor
- Applicant
- Draeger Medical, Inc.
Telford, PA, US - Received
- April 1, 2004
- Decision date
- June 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
Other 510(k)s with product code CCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121886 | Savina 300 Savina 300, Country VariantsCBK · Traditional | 08/08/2014SE |
| K133886 | Perseus A500BSZ · Traditional | 06/20/2014SE |
| K121999 | General Purpose Temperature Probe, Skin Temperature ProbeFLL · Traditional | 02/28/2013SE |
| K103035 | Smartpilot View Model MK04500BSZ · Traditional | 03/28/2012SE |
| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | 12/10/2010SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | 08/06/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | 04/23/2010SE |
| K092999 | NBP CuffDXQ · Traditional | 11/24/2009SE |
| K083050 | Evite XLCBK · Special | 12/29/2008SE |
| K081447 | Fourth Gas Module with CO2 for Primus US ApolloBSZ · Traditional | 10/08/2008SE |
Questions and answers
When was Modification to Vamos Anesthetic Gas Monitor cleared by the FDA?
Modification to Vamos Anesthetic Gas Monitor (K040847) received a 510(k) decision of Substantially Equivalent on June 17, 2004, 77 days after the submission was received.
What is the product code of K040847?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.