GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM— 510(k) K050055

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K050055 for GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM, Substantially Equivalent on 2005-02-04. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2005-01-11
Decision date: 2005-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.