510(k) K003075 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
KNIGHTSTAR 330 VENTILATOR
| Applicant | Mallinckrodt, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Dec 11, 2001 |
| Received | Oct 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2007 | Puritan Bennett Corporation Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD Terminated |
MNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.