LOFLO C5 CO2 SENSOR— 510(k) K053174

Substantially Equivalent

Respironics Novametrix, LLC

FDA 510(k) clearance K053174 for LOFLO C5 CO2 SENSOR, Substantially Equivalent on 2006-01-12. Applicant: Respironics Novametrix, LLC.

Clearance details

Applicant: Respironics Novametrix, LLC
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2005-11-14
Decision date: 2006-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Wallingford, CT, US

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.