K233266
- 510(k) number
- K233266
- Device name
- MEDIBLU ECG SYSTEM
- Applicant
- Mediblu Medical, LLC FL · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2024-06-12
- Date received
- 2023-09-29
- 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: K233266.pdf
Official FDA record: K233266
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.