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FDA 510(k)

Zio® monitor (DFG0001)

K-Number: K243650 · 2025-08-15

ApplicantiRhythm Technologies, Inc.
Decision Date2025-08-15
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zio® monitor (DFG0001) is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2025-08-15 under approval number K243650. 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 Zio® monitor (DFG0001)?

Zio® monitor (DFG0001) is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K243650.

When was Zio® monitor (DFG0001) approved by the FDA?

Zio® monitor (DFG0001) received FDA 510(k) clearance on 2025-08-15, under approval number K243650.

What company makes Zio® monitor (DFG0001)?

Zio® monitor (DFG0001) is manufactured by iRhythm Technologies, Inc..

What is the FDA product code for Zio® monitor (DFG0001)?

The FDA product code for Zio® monitor (DFG0001) is DSH.

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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