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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 K060657
Device Name ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Applicant Contact KARL-JOHAN HOLM
Correspondent
Breas Medical AB
Foretagsvagen 1
Molnlycke,  SE 435 33
Correspondent Contact KARL-JOHAN HOLM
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/13/2006
Decision Date 08/18/2006
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
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