KNIGHTSTAR 330 VENTILATOR
FDA 510(k) clearance K003075 · decided 2001-12-11
Clearance details
- K-number
- K003075
- Device name
- KNIGHTSTAR 330 VENTILATOR
- Applicant
- Mallinckrodt, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 2000-10-03
- Decision date
- 2001-12-11
- Days to decision
- 434 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330 recall (Z-0444-2007) | Puritan Bennett Corporation | 2007-01-09 |