DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX— 510(k) K012531

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K012531 for DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX, Substantially Equivalent on 2001-11-02. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2001-08-06
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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.