ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)— 510(k) K952325

Substantially Equivalent

Icor AB

FDA 510(k) clearance K952325 for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR), Substantially Equivalent on 1995-07-31. Applicant: Icor AB.

Clearance details

Applicant: Icor AB
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1995-05-18
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bromma, SE

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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.