CLUE MEDICAL AND CLUE MEDICAL BASIC— 510(k) K082013
Substantially EquivalentTelovital GmbH Telemedizin
FDA 510(k) clearance K082013 for CLUE MEDICAL AND CLUE MEDICAL BASIC, Substantially Equivalent on 2008-11-10. Applicant: Telovital GmbH Telemedizin.
Clearance details
- Applicant
- Telovital GmbH Telemedizin
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alexandria, VA, 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.