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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 K092847
Device Name 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
Original Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 gunbarrel ave.
boulder,  CO  80301
Original Contact jean simon
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/16/2009
Decision Date 03/11/2010
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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