POLARIS 2004 CAPNOGRAPH— 510(k) K040011

Substantially Equivalent

Oridion , Ltd.

FDA 510(k) clearance K040011 for POLARIS 2004 CAPNOGRAPH, Substantially Equivalent on 2004-05-13. Applicant: Oridion , Ltd..

Clearance details

Applicant: Oridion , Ltd.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2004-01-05
Decision date: 2004-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, 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.