FDA.report

510(k) K240029

Device
Zio AT® device (A100A1001)
Applicant
iRhythm Technologies, Inc.
510(k) number
K240029
Product code
QYX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-21
Date received
2024-01-04
Regulation
870.1025
Classification name
Outpatient Cardiac Telemetry
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Vishal Kanani
Address
699 8th St. Suite 600 San Francisco CA US 94103 94103

FDA Registration Numbers

Source Documents

510(k) summary PDF

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