ECC.O SYSTEM— 510(k) K050890
Substantially EquivalentDideco S.R.L.
FDA 510(k) clearance K050890 for ECC.O SYSTEM, Substantially Equivalent on 2005-05-05. Applicant: Dideco S.R.L.. Device class: 2.
Clearance details
- Applicant
- Dideco S.R.L.
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
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Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
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.