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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 K172648
Device Name Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Applicant
Devilbiss Healthcare, LLC
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact Betty Miller
Correspondent
Devilbiss Healthcare, LLC
100 Devilbiss Dr.
Somerset,  PA  15501
Correspondent Contact Sandy Figueroa
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/01/2017
Decision Date 03/23/2018
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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