K251216

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

510(k) number
K251216
Device name
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Applicant
Barbaras Development, Inc. CA · US
Product code
CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Decision date
2025-06-04
Date received
2025-04-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K251216.pdf

Official FDA record: K251216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.