510(k) K102483— SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
Substantially EquivalentSunset Healthcare Solutions, LLC
Clearance details
- Applicant
- Sunset Healthcare Solutions, LLC
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwood Village, CO, US
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
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.