PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380— 510(k) K002138
Substantially EquivalentMaersk Medical A/S
FDA 510(k) clearance K002138 for PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380, Substantially Equivalent on 2000-08-29. Applicant: Maersk Medical A/S.
Clearance details
- Applicant
- Maersk Medical A/S
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sylmar, CA, US
Adverse 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.