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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 K091919
Device Name DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
Applicant
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Applicant Contact BETTY L MILLER
Correspondent
SUNRISE MEDICAL
100 DEVILBISS DR.
SOMERSET,  PA  15501
Correspondent Contact BETTY L MILLER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/30/2009
Decision Date 09/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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