510(k) K251216

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line by Barbaras Development, Inc. — Product Code CCK

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