510(k) K142681
K142681 is an FDA 510(k) premarket notification submitted by iRhythm Technologies, Inc. for the device "ZEUS (ZIO ECG Utilization Service) System". The FDA issued a decision of Substantially Equivalent on November 21, 2014. 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
- November 21, 2014
- Date Received
- September 19, 2014
- Clearance Type
- Special
- 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