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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K020386
Device Name INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Applicant Contact EDWARD A KNOLL
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Correspondent Contact EDWARD A KNOLL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/06/2002
Decision Date 07/02/2002
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
Recalls CDRH Recalls
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