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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 K071069
Device Name MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
Applicant
VIASYS SLEEP SYSTEMS, LLC.
9305 ETON AVENUE
CHATSWORTH,  CA  91311
Applicant Contact KEITH BOSECKER
Correspondent
VIASYS SLEEP SYSTEMS, LLC.
9305 ETON AVENUE
CHATSWORTH,  CA  91311
Correspondent Contact KEITH BOSECKER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/16/2007
Decision Date 06/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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