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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 K053388
Device Name MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
Original Applicant
PURITAN BENNETT CORP.
4280 hacienda dr.
pleasanton,  CA  94588 -2719
Original Contact james bonds
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/05/2005
Decision Date 04/04/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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