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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 K042483
Device Name INVACARE PRO, COMPACT AND PORTABLE DESKTOP
Applicant
Invacare Corporation
One Invacare Way
Elyria,  OH  44035 -4190
Applicant Contact CARROLL MARTIN
Correspondent
Invacare Corporation
One Invacare Way
Elyria,  OH  44035 -4190
Correspondent Contact CARROLL MARTIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/13/2004
Decision Date 01/06/2005
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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