MCARE 300 VITAL SIGNS MONITOR, MODEL 91220— 510(k) K062095

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K062095 for MCARE 300 VITAL SIGNS MONITOR, MODEL 91220, Substantially Equivalent on 2006-09-29. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2006-07-24
Decision date: 2006-09-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Issaquah, WA, 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.