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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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