CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
FDA 510(k) K143127 · Dispo-Med (Malaysia) Sdn Bhd
510(k) numberK143127
Submission
- Device name
- CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
- Applicant
- Dispo-Med (Malaysia) Sdn Bhd
Petaling Jaya , Selangor Darul Ehsan, MY - Received
- October 31, 2014
- Decision date
- February 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
Questions and answers
When was CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style cleared by the FDA?
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style (K143127) received a 510(k) decision of Substantially Equivalent on February 13, 2015, 105 days after the submission was received.
What is the product code of K143127?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.