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FDA 510(k)

Zio AT® device (A100A1001)

K-Number: K240177 · 2024-10-30

ApplicantiRhythm Technologies, Inc.
Decision Date2024-10-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio AT® device (A100A1001) is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-30 under 510(k) number K240177. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zio AT® device (A100A1001)?

Zio AT® device (A100A1001) is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K240177.

When did Zio AT® device (A100A1001) receive FDA 510(k) clearance?

Zio AT® device (A100A1001) received FDA 510(k) clearance on 2024-10-30, under 510(k) number K240177.

Who is the listed applicant for Zio AT® device (A100A1001)?

The FDA 510(k) record lists iRhythm Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zio AT® device (A100A1001)?

The FDA product code for Zio AT® device (A100A1001) is DSI.

Related Clinical Trials

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.

NCT07205367Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA IICOMPLETED

Other records listing iRhythm Technologies, Inc. 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.

K252859ZEUS Platform (FG0501US)K243650Zio® monitor (DFG0001)K240029Zio AT® device (A100A1001)K222389ZEUS SystemK213409ZEUS System (Zio Watch)K202527Zio ECG Utilization Software (ZEUS) System

View all 11 devices →

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.K192732BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc.

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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