CO2 Easy
FDA 510(k) K070128 · Westmed, Inc.
510(k) numberK070128
Submission
- Device name
- CO2 Easy
- Applicant
- Westmed, Inc.
Tucson, AZ, US - Received
- January 16, 2007
- Decision date
- February 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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| K072220 | Pedi CO2 EasyCCK · Traditional | 08/23/2007SE |
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Questions and answers
When was CO2 Easy cleared by the FDA?
CO2 Easy (K070128) received a 510(k) decision of Substantially Equivalent on February 15, 2007, 30 days after the submission was received.
What is the product code of K070128?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.