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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 K083693
Device Name PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
2101 FARADAY AVENUE
CARLSBAD,  CA  92008
Applicant Contact KIM BLOOM
Correspondent
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
2101 FARADAY AVENUE
CARLSBAD,  CA  92008
Correspondent Contact KIM BLOOM
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/12/2008
Decision Date 04/02/2009
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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