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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 K071163
Device Name WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
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 Received04/26/2007
Decision Date 07/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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