MEDIBLU ECG SYSTEM— 510(k) K233266
Substantially EquivalentMediblu Medical, LLC
FDA 510(k) clearance K233266 for MEDIBLU ECG SYSTEM, Substantially Equivalent on 2024-06-12. Applicant: Mediblu Medical, LLC.
Clearance details
- Applicant
- Mediblu Medical, LLC
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Doral, FL, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.