CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style— 510(k) K143127

Substantially Equivalent

Dispo-Med (Malaysia) Sdn Bhd

FDA 510(k) clearance K143127 for CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style, Substantially Equivalent on 2015-02-13. Applicant: Dispo-Med (Malaysia) Sdn Bhd.

Clearance details

Applicant: Dispo-Med (Malaysia) Sdn Bhd
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2014-10-31
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaling Jaya , Selangor Darul Ehsan, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.