510(k) K251216
K251216 is an FDA 510(k) premarket notification submitted by Barbaras Development, Inc. for the device "0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line". The FDA issued a decision of Substantially Equivalent on June 4, 2025. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2025
- Date Received
- April 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type