K243650
- 510(k) number
- K243650
- Device name
- Zio® monitor (DFG0001)
- Applicant
- iRhythm Technologies, Inc. CA · US
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2025-08-15
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243650.pdf
Official FDA record: K243650
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.