SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)— 510(k) K112962

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K112962 for SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930), Substantially Equivalent on 2011-11-02. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2011-10-05
Decision date: 2011-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Issaquah, WA, 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.