510(k) K243650
K243650 is an FDA 510(k) premarket notification submitted by iRhythm Technologies, Inc. for the device "Zio® monitor (DFG0001)". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. iRhythm Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2025
- Date Received
- November 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type