510(k) K181502
K181502 is an FDA 510(k) premarket notification submitted by iRhythm Technologies, Inc. for the device "Zio AT ECG Monitoring System, ZEUS System". The FDA issued a decision of Substantially Equivalent on August 29, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. iRhythm Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2018
- Date Received
- June 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type