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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 K110083
Device Name V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
Applicant
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92130
Applicant Contact MARY FUNK
Correspondent
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92130
Correspondent Contact MARY FUNK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/11/2011
Decision Date 01/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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