DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE— 510(k) K071020

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K071020 for DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE, Substantially Equivalent on 2007-06-18. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2007-04-10
Decision date: 2007-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.