GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM— 510(k) K041524

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K041524 for GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM, Substantially Equivalent on 2004-09-20. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2004-06-08
Decision date: 2004-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.