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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 K072290
Device Name PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
Applicant
DIMA ITALIA SRL
4655 KIRKWOOD CT.
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
DIMA ITALIA SRL
4655 KIRKWOOD CT.
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number868.5935
Classification Product Code
BYT  
Date Received08/16/2007
Decision Date 05/29/2008
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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