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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 K011229
Device Name DEVILBISS 9000 SERIES CPAP, MODEL 9001
Applicant
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact JIM FROEHLICH
Correspondent
SUNRISE MEDICAL HHG, INC.
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact JIM FROEHLICH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/23/2001
Decision Date 07/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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