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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
Applicant
RESPIRONICS, INC.
2271 COSMOS COURT
CARLSBAD,  CA  92009 -1517
Applicant Contact ANIL BHALANI
Correspondent
RESPIRONICS, INC.
2271 COSMOS COURT
CARLSBAD,  CA  92009 -1517
Correspondent Contact ANIL BHALANI
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/29/2003
Decision Date 01/21/2004
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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