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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, Manual (Resuscitator)
510(k) Number K012271
Device Name ACUTEVENTILATOR
Applicant
Impoex International, Ltd.
500 Eagle Way #18
Little River,  SC  29566
Applicant Contact SIVERT CLAESSON
Correspondent
Impoex International, Ltd.
500 Eagle Way #18
Little River,  SC  29566
Correspondent Contact SIVERT CLAESSON
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/19/2001
Decision Date 10/04/2002
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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