KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E— 510(k) K010923

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K010923 for KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E, Substantially Equivalent on 2002-01-23. Applicant: Siemens Elema AB.

Clearance details

Applicant: Siemens Elema AB
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2001-03-27
Decision date: 2002-01-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Iselin, NJ, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.