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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Minimal Ventilatory Support, Facility Use Ventilator
510(k) Number K973004
Device Name KNIGHTSTAR 335
Applicant
Puritan Bennett Corp.
9728 Pflumm Rd.
P.O.Box 15915
Lenexa,  KS  66215
Applicant Contact C. MARSHALL SMITH
Correspondent
Puritan Bennett Corp.
9728 Pflumm Rd.
P.O.Box 15915
Lenexa,  KS  66215
Correspondent Contact C. MARSHALL SMITH
Regulation Number868.5895
Classification Product Code
MNT  
Date Received08/13/1997
Decision Date 07/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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