K230265
- 510(k) number
- K230265
- Device name
- MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- Applicant
- Infobionic, Inc. MA · US
- Product code
- DSI — Detector And Alarm, Arrhythmia
- Decision date
- 2023-10-06
- Date received
- 2023-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K230265.pdf
Official FDA record: K230265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.