VICARDIO 12B— 510(k) K082380
Substantially EquivalentEnergy-Lab Technologies GmbH
FDA 510(k) clearance K082380 for VICARDIO 12B, Substantially Equivalent on 2008-12-03. Applicant: Energy-Lab Technologies GmbH.
Clearance details
- Applicant
- Energy-Lab Technologies GmbH
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasbrouck Heights, NJ, 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.