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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 K061057
Device Name BREAS 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 Received04/17/2006
Decision Date 06/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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