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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K050918
Device Name KOO AMERICAS VALVE PEEP, MODEL KM-809
Applicant
Koo Americas, Inc.
1050-C Nine N. Dr.
Alpharetta,  GA  30004
Applicant Contact WILLIAM SLEVIN
Correspondent
Koo Americas, Inc.
1050-C Nine N. Dr.
Alpharetta,  GA  30004
Correspondent Contact WILLIAM SLEVIN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/12/2005
Decision Date 06/06/2005
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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