SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E— 510(k) K010925

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K010925 for SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E, Substantially Equivalent on 2001-12-18. Applicant: Siemens Elema AB.

Clearance details

Applicant: Siemens Elema AB
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2001-03-27
Decision date: 2001-12-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Iselin, NJ, 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.