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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, Facility Use
510(k) Number K993071
Device Name PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
Applicant
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Applicant Contact DELTON WEST
Correspondent
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Correspondent Contact DELTON WEST
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/14/1999
Decision Date 11/24/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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