DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01— 510(k) K013246

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K013246 for DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01, Substantially Equivalent on 2001-12-11. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2001-09-28
Decision date: 2001-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.