MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220— 510(k) K082045

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K082045 for MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220, Substantially Equivalent on 2008-08-01. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2008-07-18
Decision date: 2008-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Las Vegas, NV, 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.