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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K043282
Device Name DEVILBISS AUTOADJUST, MODEL 9054 SERIES
Applicant
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact STEPHEN KREPELKA
Correspondent
Sunrise Medical
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact STEPHEN KREPELKA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/26/2004
Decision Date 02/11/2005
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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