K252839
- 510(k) number
- K252839
- Device name
- ZywieZ3 Sensor & Adhesive
- Applicant
- Zywie, Inc. GA · US
- Product code
- MWJ — Electrocardiograph, Ambulatory (Without Analysis)
- Decision date
- 2026-06-18
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K252839.pdf
Official FDA record: K252839
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.