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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
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92009
Applicant Contact MARY FUNK
Correspondent
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92009
Correspondent 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 (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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