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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K082657
Device Name RTX RESPIRATOR
Applicant
MEDIVENT LIMITED
MARYLAND HOUSE, 10 THE DOWNAGE
LONDON, ENGLAND,  GB NW4 1AA
Applicant Contact SHAHAR HAYEK
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number868.5935
Classification Product Code
BYT  
Date Received09/12/2008
Decision Date 10/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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