SPACELABS MEDICAL ECG ANALYSIS SYSTEM— 510(k) K962930

Name: FDA 510(k) clearance K962930
Creator: U.S. Food and Drug Administration
Published: 1997-04-25

Unknown

Spacelabs Medical, Inc.

FDA 510(k) clearance K962930 for SPACELABS MEDICAL ECG ANALYSIS SYSTEM, Unknown on 1997-04-25. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 1996-07-29
Decision date: 1997-04-25
Decision: Unknown
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.