KNIGHTSTAR 330 VENTILATOR— 510(k) K003075
Substantially Equivalent - Subject to Tracking Reg.Mallinckrodt, Inc.
FDA 510(k) clearance K003075 for KNIGHTSTAR 330 VENTILATOR, Substantially Equivalent - Subject to Tracking Reg. on 2001-12-11. Applicant: Mallinckrodt, Inc..
Clearance details
- Applicant
- Mallinckrodt, Inc.
- Product code
- Code MNT
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Adverse events under product code MNT
product code MNT- Death
- 118
- Injury
- 324
- Malfunction
- 25,451
- Other
- 2
- Total
- 25,895
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.