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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 a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-30 under approval 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. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K240177.

When was Zio AT® device (A100A1001) approved by the FDA?

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

What company makes Zio AT® device (A100A1001)?

Zio AT® device (A100A1001) is manufactured by iRhythm Technologies, Inc..

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

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

Other Devices by iRhythm Technologies, Inc.

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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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