510(k) K932724— SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY

Substantially Equivalent

Spacelabs Medical, Inc.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 1993-06-07
Decision date: 1993-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.