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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 K203210
Device Name Invacare Platinum 5NXG Oxygen Concentrator
Applicant
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Applicant Contact Elijah Wreh
Correspondent
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Correspondent Contact Elijah Wreh
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/30/2020
Decision Date 04/12/2021
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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