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FDA 510(k)

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

K-Number: K091075 · 2009-07-21

ApplicantiRhythm Technologies, Inc.
Decision Date2009-07-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM 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 2009-07-21 under 510(k) number K091075. 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 (ZIO ECG UTILIZATION SERVICE) SYSTEM?

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-21. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K091075.

When did ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM receive FDA 510(k) clearance?

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM received FDA 510(k) clearance on 2009-07-21, under 510(k) number K091075.

Who is the listed applicant for ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM?

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 ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM?

The FDA product code for ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM is DQK.

Related Clinical Trials

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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)K240177Zio AT® device (A100A1001)K240029Zio AT® device (A100A1001)K222389ZEUS SystemK213409ZEUS System (Zio Watch)

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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