AT-Patch (ATP-C130/ATP-C70)— 510(k) K242583

Substantially Equivalent

Atsens Co., Ltd.

FDA 510(k) clearance K242583 for AT-Patch (ATP-C130/ATP-C70), Substantially Equivalent on 2025-05-02. Applicant: Atsens Co., Ltd..

Clearance details

Applicant: Atsens Co., Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2024-08-30
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.