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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
510(k) Number K003075
Device Name KNIGHTSTAR 330 VENTILATOR
Applicant
MALLINCKRODT, INC.
675 MCDONNELL BLVD.
BLDG. 10-2-N
ST. LOUIS,  MO  63134
Applicant Contact ANTHONY MULLIN
Correspondent
MALLINCKRODT, INC.
675 MCDONNELL BLVD.
BLDG. 10-2-N
ST. LOUIS,  MO  63134
Correspondent Contact ANTHONY MULLIN
Regulation Number868.5895
Classification Product Code
MNT  
Date Received10/03/2000
Decision Date 12/11/2001
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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