SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847— 510(k) K062278

Name: FDA 510(k) clearance K062278
Creator: U.S. Food and Drug Administration
Published: 2006-09-19

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K062278 for SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847, Substantially Equivalent on 2006-09-19. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Product code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2006-08-07
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

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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.