The following data is part of a premarket notification filed by Mallinckrodt, Inc. with the FDA for Knightstar 330 Ventilator.
| Device ID | K003075 |
| 510k Number | K003075 |
| Device Name: | KNIGHTSTAR 330 VENTILATOR |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | MALLINCKRODT, INC. 675 MCDONNELL BLVD. BLDG. 10-2-N St. Louis, MO 63134 |
| Contact | Anthony Mullin |
| Correspondent | Anthony Mullin MALLINCKRODT, INC. 675 MCDONNELL BLVD. BLDG. 10-2-N St. Louis, MO 63134 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2001-12-11 |