THERAGEM PROFESSIONAL T1002— 510(k) K081505
Substantially EquivalentMedica Health, Ltd.
FDA 510(k) clearance K081505 for THERAGEM PROFESSIONAL T1002, Substantially Equivalent on 2008-11-19. Applicant: Medica Health, Ltd..
Clearance details
- Applicant
- Medica Health, Ltd.
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Beach, FL, US
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.