CO2 monitoring line with and without in-line filter— 510(k) K143150

Substantially Equivalent

Besmed Health Business Corp

FDA 510(k) clearance K143150 for CO2 monitoring line with and without in-line filter, Substantially Equivalent on 2015-02-05. Applicant: Besmed Health Business Corp.

Clearance details

Applicant: Besmed Health Business Corp
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2014-11-03
Decision date: 2015-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.