SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE— 510(k) K090556

Substantially Equivalent

Spacelabs Healthcare Medical Equipment (Suzhou) CO

FDA 510(k) clearance K090556 for SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE, Substantially Equivalent on 2009-04-30. Applicant: Spacelabs Healthcare Medical Equipment (Suzhou) CO.

Clearance details

Applicant: Spacelabs Healthcare Medical Equipment (Suzhou) CO
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2009-03-02
Decision date: 2009-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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.