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

Name: FDA 510(k) clearance K082045
Creator: U.S. Food and Drug Administration
Published: 2008-08-01

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.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
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 ↗

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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.