K062278

Substantially Equivalent

SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847

Applicant: Spacelabs Medical, Inc.
Product code: MSX
Advisory panel: Cardiovascular
Date received: 2006-08-07
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Issaquah, WA, US

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.