Atsens Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Atsens Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: AT-Patch (ATP-C130/ATP-C70), AT-Patch ECG Analysis System
2
Total
2
Cleared
0
Denied
Atsens Co., Ltd. has 2 FDA 510(k) cleared medical devices. Based in Seongnam-Si, KR.
Latest FDA clearance: May 2025. Active since 2022. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Atsens Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bt Solutions, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Atsens Co., Ltd.
2 devices