MERCURY VCO2 MODULE WITH CAPNOSTAT 5— 510(k) K080652

Substantially Equivalent

Respironics Novametrix, LLC

FDA 510(k) clearance K080652 for MERCURY VCO2 MODULE WITH CAPNOSTAT 5, Substantially Equivalent on 2008-06-20. Applicant: Respironics Novametrix, LLC.

Clearance details

Applicant: Respironics Novametrix, LLC
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2008-03-07
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Wallingford, CT, US

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.