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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 K060405
Device Name SOYALA, SOYALA BLUE
Applicant
Weinmann Gerate Fur Medizin GmbH + Co. KG
Kronsaalsweg 40
Hamburg,  DE 22525
Applicant Contact ECKHARDT ALBERS
Correspondent
Weinmann Gerate Fur Medizin GmbH + Co. KG
Kronsaalsweg 40
Hamburg,  DE 22525
Correspondent Contact ECKHARDT ALBERS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/16/2006
Decision Date 06/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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