BACT-TRAP HEPA MIDI— 510(k) K093426
Substantially EquivalentPharma Systems AB
FDA 510(k) clearance K093426 for BACT-TRAP HEPA MIDI, Substantially Equivalent on 2010-02-22. Applicant: Pharma Systems AB.
Clearance details
- Applicant
- Pharma Systems AB
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, 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.