Athena GTX Device Management Suite (ADMS) Software— 510(k) K173203

Name: FDA 510(k) clearance K173203
Creator: U.S. Food and Drug Administration
Published: 2018-03-14

Substantially Equivalent

Athena Gtx

FDA 510(k) clearance K173203 for Athena GTX Device Management Suite (ADMS) Software, Substantially Equivalent on 2018-03-14. Applicant: Athena Gtx. Device class: 2.

Clearance details

Applicant: Athena Gtx
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2017-10-02
Decision date: 2018-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson, IA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.