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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 K041412
Device Name ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
Original Applicant
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad,  CA  92009
Original Contact mary funk
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/27/2004
Decision Date 06/18/2004
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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