Empty EVA Bag— 510(k) K193528
Substantially EquivalentHaemotronic S.P.A.
FDA 510(k) clearance K193528 for Empty EVA Bag, Substantially Equivalent on 2020-07-22. Applicant: Haemotronic S.P.A..
Clearance details
- Applicant
- Haemotronic S.P.A.
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.