SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION— 510(k) K962970

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K962970 for SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION, Substantially Equivalent on 1997-03-25. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1996-07-31
Decision date: 1997-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.