TESLAGUARD, MODEL EFT G04— 510(k) K052119
Substantially EquivalentMammendorfer Institute For Physics & Medicine GmbH
FDA 510(k) clearance K052119 for TESLAGUARD, MODEL EFT G04, Substantially Equivalent on 2006-01-03. Applicant: Mammendorfer Institute For Physics & Medicine GmbH.
Clearance details
- Applicant
- Mammendorfer Institute For Physics & Medicine GmbH
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden, CO, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.