SPACELABS HEALTHCARE CARDIOEXPRESS— 510(k) K130207

Name: FDA 510(k) clearance K130207
Creator: U.S. Food and Drug Administration
Published: 2013-07-23

Substantially Equivalent

Spacelabs Healthcare, Ltd.

FDA 510(k) clearance K130207 for SPACELABS HEALTHCARE CARDIOEXPRESS, Substantially Equivalent on 2013-07-23. Applicant: Spacelabs Healthcare, Ltd.. Device class: 2.

Clearance details

Applicant: Spacelabs Healthcare, Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2013-01-28
Decision date: 2013-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.