CONFIDANT 2.0— 510(k) K062215

Name: FDA 510(k) clearance K062215
Creator: U.S. Food and Drug Administration
Published: 2006-10-16

Substantially Equivalent

Confidant, Inc.

FDA 510(k) clearance K062215 for CONFIDANT 2.0, Substantially Equivalent on 2006-10-16. Applicant: Confidant, Inc.. Device class: 2.

Clearance details

Applicant: Confidant, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2006-08-01
Decision date: 2006-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.