AESPIRE 7900, AESPIRE VIEW— 510(k) K092864

Substantially Equivalent

Datex-Ohmeda Inc., A Division of Instrumentarium C

FDA 510(k) clearance K092864 for AESPIRE 7900, AESPIRE VIEW, Substantially Equivalent on 2010-01-12. Applicant: Datex-Ohmeda Inc., A Division of Instrumentarium C.

Clearance details

Applicant: Datex-Ohmeda Inc., A Division of Instrumentarium C
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2009-09-17
Decision date: 2010-01-12
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.