Medisystem Pacs— 510(k) K223048
Substantially EquivalentMedilab Manutencao E Sitemas Ltda
FDA 510(k) clearance K223048 for Medisystem Pacs, Substantially Equivalent on 2023-06-23. Applicant: Medilab Manutencao E Sitemas Ltda.
Clearance details
- Applicant
- Medilab Manutencao E Sitemas Ltda
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rio De Janeiro, BR
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.