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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K051284
Device Name MD TURBO
Applicant
Respirics, Inc.
1700 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact EDWARD M BASILE
Correspondent
Respirics, Inc.
1700 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact EDWARD M BASILE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/13/2005
Decision Date 06/22/2005
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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