Zio AT ECG Monitoring System— 510(k) K163512
Substantially EquivalentiRhythm Technologies, Inc.
FDA 510(k) clearance K163512 for Zio AT ECG Monitoring System, Substantially Equivalent on 2017-06-02. Applicant: iRhythm Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- iRhythm Technologies, Inc.
- Product code
- Code QYX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code QYX
view allMore clearances from iRhythm Technologies, Inc.
view allAdverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K163512
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163512.
Data sourced from openFDA. This site is unofficial and independent of the FDA.