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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
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