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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 K072450
Device Name ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
Applicant
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92011
Applicant Contact MARA CALER
Correspondent
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92011
Correspondent Contact MARA CALER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/31/2007
Decision Date 12/12/2007
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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