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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K112783
Device Name MANUJET III
Applicant
VBM Medizintechnik GmbH
1, Einsteinstrasse
Sulz Am Neckar,
Baden-Wurttemberg,  DE 72172
Applicant Contact ANKE BLOCHER
Correspondent
VBM Medizintechnik GmbH
1, Einsteinstrasse
Sulz Am Neckar,
Baden-Wurttemberg,  DE 72172
Correspondent Contact ANKE BLOCHER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/26/2011
Decision Date 12/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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