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FDA 510(k)

AT-Patch (ATP-C130/ATP-C70)

K-Number: K242583 · 2025-05-02

ApplicantAtsens Co., Ltd.
Decision Date2025-05-02
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AT-Patch (ATP-C130/ATP-C70) is a medical device manufactured by Atsens Co., Ltd.. It received FDA 510(k) clearance on 2025-05-02 under approval number K242583. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT-Patch (ATP-C130/ATP-C70)?

AT-Patch (ATP-C130/ATP-C70) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Atsens Co., Ltd.. The 510(k) number is K242583.

When was AT-Patch (ATP-C130/ATP-C70) approved by the FDA?

AT-Patch (ATP-C130/ATP-C70) received FDA 510(k) clearance on 2025-05-02, under approval number K242583.

What company makes AT-Patch (ATP-C130/ATP-C70)?

AT-Patch (ATP-C130/ATP-C70) is manufactured by Atsens Co., Ltd..

What is the FDA product code for AT-Patch (ATP-C130/ATP-C70)?

The FDA product code for AT-Patch (ATP-C130/ATP-C70) is DSH.

Other Devices by Atsens Co., Ltd.

K203638AT-Patch ECG Analysis System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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