OPTUM TELEHEALTH APPLICATION— 510(k) K130971

Name: FDA 510(k) clearance K130971
Creator: U.S. Food and Drug Administration
Published: 2013-10-23

Substantially Equivalent

Optumhealth Care Solutions, Inc.

FDA 510(k) clearance K130971 for OPTUM TELEHEALTH APPLICATION, Substantially Equivalent on 2013-10-23. Applicant: Optumhealth Care Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Optumhealth Care Solutions, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2013-04-08
Decision date: 2013-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundas, CA

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.