C-CO2 Colorimetric CO2 Indicator
FDA 510(k) K050066 · Marquest Medical Products, Inc.
510(k) numberK050066
Submission
- Device name
- C-CO2 Colorimetric CO2 Indicator
- Applicant
- Marquest Medical Products, Inc.
Englewood, CO, US - Received
- January 12, 2005
- Decision date
- March 1, 2005
- 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
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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | 07/16/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | 01/14/1997SE |
| K962220 | Heated Wire Circuits for SCT 3000 Heated HumidifierBZE · Traditional | 01/14/1997SE |
| K961838 | Respirgard II, SpirogardCAH · Traditional | 10/18/1996SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | 10/18/1996SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | 02/01/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | 10/11/1990SE |
| K902632 | Gas-Lyte 1CC and 3CC Arterial Blood SamplersCBT · Traditional | 09/04/1990SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | 08/17/1990SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | 07/15/1988SE |
Questions and answers
When was C-CO2 Colorimetric CO2 Indicator cleared by the FDA?
C-CO2 Colorimetric CO2 Indicator (K050066) received a 510(k) decision of Substantially Equivalent on March 1, 2005, 48 days after the submission was received.
What is the product code of K050066?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.