510(k) K240177
K240177 is an FDA 510(k) premarket notification submitted by iRhythm Technologies, Inc. for the device "Zio AT® device (A100A1001)". The FDA issued a decision of Substantially Equivalent on October 30, 2024. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. iRhythm Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2024
- Date Received
- January 23, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type