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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 K034040
Device Name ESPRIT VENTILATOR, MODEL V1000
Original Applicant
RESPIRONICS, INC.
2271 cosmos court
carlsbad,  CA  92009 1517
Original Contact anil bhalani
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/29/2003
Decision Date 01/21/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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