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FDA 510(k)

ZIO PATCH

K-Number: K121319 · 2012-07-18

ApplicantiRhythm Technologies, Inc.
Decision Date2012-07-18
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZIO PATCH 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 2012-07-18 under 510(k) number K121319. 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 PATCH?

ZIO PATCH is a medical device that received FDA 510(k) clearance on 2012-07-18. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K121319.

When did ZIO PATCH receive FDA 510(k) clearance?

ZIO PATCH received FDA 510(k) clearance on 2012-07-18, under 510(k) number K121319.

Who is the listed applicant for ZIO PATCH?

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 PATCH?

The FDA product code for ZIO PATCH is DSH.

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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: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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