Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System— 510(k) K142468

Name: FDA 510(k) clearance K142468
Creator: U.S. Food and Drug Administration
Published: 2015-07-11

Substantially Equivalent

Cardiac Insight, Inc.

FDA 510(k) clearance K142468 for Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System, Substantially Equivalent on 2015-07-11. Applicant: Cardiac Insight, Inc.. Device class: 2.

Clearance details

Applicant: Cardiac Insight, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2014-09-03
Decision date: 2015-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.