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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 K023350
Device Name ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
Original Applicant
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct.
carlsbad,  CA  92009
Original Contact mary funk
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
BZG  
Date Received10/07/2002
Decision Date 11/06/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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