K243252
- 510(k) number
- K243252
- Device name
- ZBPro Diagnostic
- Applicant
- Zbeats, Inc. NY · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2025-07-10
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243252.pdf
Official FDA record: K243252
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.