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FDA 510(k)

ZEUS System (Zio Watch)

K-Number: K213409 · 2022-07-19

ApplicantiRhythm Technologies, Inc.
Decision Date2022-07-19
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZEUS System (Zio Watch) is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2022-07-19 under approval number K213409. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS System (Zio Watch)?

ZEUS System (Zio Watch) is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K213409.

When was ZEUS System (Zio Watch) approved by the FDA?

ZEUS System (Zio Watch) received FDA 510(k) clearance on 2022-07-19, under approval number K213409.

What company makes ZEUS System (Zio Watch)?

ZEUS System (Zio Watch) is manufactured by iRhythm Technologies, Inc..

What is the FDA product code for ZEUS System (Zio Watch)?

The FDA product code for ZEUS System (Zio Watch) is DQK.

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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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