CO2 CLIP— 510(k) K023820

Substantially Equivalent

Bregas AB

FDA 510(k) clearance K023820 for CO2 CLIP, Substantially Equivalent on 2003-05-07. Applicant: Bregas AB.

Clearance details

Applicant: Bregas AB
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2002-11-15
Decision date: 2003-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bromma, SE

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.