OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072— 510(k) K023289

Substantially Equivalent

Drager Medizintechnik GmbH

FDA 510(k) clearance K023289 for OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072, Substantially Equivalent on 2003-01-15. Applicant: Drager Medizintechnik GmbH.

Clearance details

Applicant: Drager Medizintechnik GmbH
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2002-10-02
Decision date: 2003-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Telford, PA, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.