K250356
- 510(k) number
- K250356
- Device name
- MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- Applicant
- Infobionic, Inc. MA · US
- Product code
- DSI — Detector And Alarm, Arrhythmia
- Decision date
- 2025-07-29
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K250356.pdf
Official FDA record: K250356
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.