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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 K063650
Device Name VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
Applicant
Puritan Bennett Corp.
5391 Priestly Dr., Suite 100
Carlsbad,  CA  92008
Applicant Contact PATRICK GARVEY
Correspondent
Puritan Bennett Corp.
5391 Priestly Dr., Suite 100
Carlsbad,  CA  92008
Correspondent Contact PATRICK GARVEY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/08/2006
Decision Date 02/15/2007
Decision Substantially Equivalent (SESE)
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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