Garmin ECG App— 510(k) K221774

Substantially Equivalent

Garmin International, Inc.

FDA 510(k) clearance K221774 for Garmin ECG App, Substantially Equivalent on 2023-01-12. Applicant: Garmin International, Inc.. Device class: 2.

Clearance details

Applicant: Garmin International, Inc.
Product code: Code QDA
Device class: Class 2
Regulation: 21 CFR 870.2345
Advisory panel: Cardiovascular
Date received: 2022-06-21
Decision date: 2023-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Olathe, KS, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.