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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 K021573
Device Name PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
Applicant
PURITAN-BENNETT
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Applicant Contact GINA TO
Correspondent
PURITAN-BENNETT
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Correspondent Contact GINA TO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/14/2002
Decision Date 08/13/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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