510(k) K003075
K003075 is an FDA 510(k) premarket notification submitted by Mallinckrodt, Inc. for the device "KNIGHTSTAR 330 VENTILATOR". The FDA issued a decision of ST on December 11, 2001. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Mallinckrodt, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- December 11, 2001
- Date Received
- October 3, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sv70 Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type