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510(k) K081471

ECARD AND CCARD by iRhythm Technologies, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2008
Date Received
May 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

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  • K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (August 23, 2019)
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