CARDIOLINE AR 600, AR 1200, AR 2100— 510(k) K051534
Substantially EquivalentEt Medical Devices Spa
FDA 510(k) clearance K051534 for CARDIOLINE AR 600, AR 1200, AR 2100, Substantially Equivalent on 2005-10-05. Applicant: Et Medical Devices Spa.
Clearance details
- Applicant
- Et Medical Devices Spa
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cavareno, IT
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.