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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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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