SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION— 510(k) K962811

Name: FDA 510(k) clearance K962811
Creator: U.S. Food and Drug Administration
Published: 1997-06-24

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K962811 for SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION, Substantially Equivalent on 1997-06-24. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 1996-07-18
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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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.