Rooti Rx ECG Event Recorder, Rooti Link APP Software— 510(k) K163694

Substantially Equivalent

Rooti Labs , Ltd.

FDA 510(k) clearance K163694 for Rooti Rx ECG Event Recorder, Rooti Link APP Software, Substantially Equivalent on 2017-11-07. Applicant: Rooti Labs , Ltd..

Clearance details

Applicant: Rooti Labs , Ltd.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2016-12-28
Decision date: 2017-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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.