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FDA 510(k)

AT-Patch ECG Analysis System

K-Number: K203638 · 2022-10-12

ApplicantAtsens Co., Ltd.
Decision Date2022-10-12
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AT-Patch ECG Analysis System is a medical device manufactured by Atsens Co., Ltd.. It received FDA 510(k) clearance on 2022-10-12 under approval number K203638. 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 ECG Analysis System?

AT-Patch ECG Analysis System is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Atsens Co., Ltd.. The 510(k) number is K203638.

When was AT-Patch ECG Analysis System approved by the FDA?

AT-Patch ECG Analysis System received FDA 510(k) clearance on 2022-10-12, under approval number K203638.

What company makes AT-Patch ECG Analysis System?

AT-Patch ECG Analysis System is manufactured by Atsens Co., Ltd..

What is the FDA product code for AT-Patch ECG Analysis System?

The FDA product code for AT-Patch ECG Analysis System is DSH.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Atsens Co., Ltd.

K242583AT-Patch (ATP-C130/ATP-C70)

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

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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