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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 the device name listed in this FDA 510(k) record. The listed applicant is Atsens Co., Ltd.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) 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. The listed applicant is Atsens Co., Ltd.. The 510(k) number is K242583.

When did AT-Patch (ATP-C130/ATP-C70) receive FDA 510(k) clearance?

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

Who is the listed applicant for AT-Patch (ATP-C130/ATP-C70)?

The FDA 510(k) record lists Atsens Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Atsens Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203638AT-Patch ECG Analysis System

Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K232670HiCardi+ H100MEZOO Co., Ltd.

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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