DOSI-FLOW, MODELS 20 & 30— 510(k) K952810
Substantially EquivalentLeventon, S.A.
FDA 510(k) clearance K952810 for DOSI-FLOW, MODELS 20 & 30, Substantially Equivalent on 1995-09-08. Applicant: Leventon, S.A.. Device class: 2.
Clearance details
- Applicant
- Leventon, S.A.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
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More clearances from Leventon, S.A.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.