Zio AT ECG Monitoring System
K-Number: K163512 · 2017-06-02
Device Summary
Frequently Asked Questions
What is the Zio AT ECG Monitoring System?
Zio AT ECG Monitoring System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K163512.
When did Zio AT ECG Monitoring System receive FDA 510(k) clearance?
Zio AT ECG Monitoring System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163512.
Who is the listed applicant for Zio AT ECG Monitoring 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 Zio AT ECG Monitoring System?
The FDA product code for Zio AT ECG Monitoring System is QYX.
Related Clinical Trials
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.
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.
Related Devices (Code: QYX)
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.
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.