CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),— 510(k) K131410

Substantially Equivalent

Southmedic, Inc.

FDA 510(k) clearance K131410 for CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),, Substantially Equivalent on 2014-01-13. Applicant: Southmedic, Inc..

Clearance details

Applicant: Southmedic, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2013-05-15
Decision date: 2014-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrie, Ontario, CA

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.