510(k) K213933
K213933 is an FDA 510(k) premarket notification submitted by Careox, LLC for the device "Percent Oxygen Sensors". The FDA issued a decision of Substantially Equivalent on August 19, 2022. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2022
- Date Received
- December 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type