CAPNOSTREAM20 WITH MICROMEDICO2 MODULE— 510(k) K094012

Substantially Equivalent

Oridion Capnography, Inc.

FDA 510(k) clearance K094012 for CAPNOSTREAM20 WITH MICROMEDICO2 MODULE, Substantially Equivalent on 2010-05-12. Applicant: Oridion Capnography, Inc..

Clearance details

Applicant: Oridion Capnography, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2009-12-29
Decision date: 2010-05-12
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.