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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 K200890
Device Name Invacare Perfecto2V Oxygen Concentrator
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Applicant Contact Elijah Wreh
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Correspondent Contact Elijah Wreh
Regulation Number868.5440
Classification Product Code
Date Received04/03/2020
Decision Date 08/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls