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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 K250805
Device Name DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
Applicant
Devilbiss Healthcare, LLC
100 Devilbiss Dr.
Somerset,  PA  15501
Applicant Contact Christy Foreman
Correspondent
Devilbiss Healthcare, LLC
99 Seaview Boulevard
Port Washington,  NY  11050
Correspondent Contact Susan Scott
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/17/2025
Decision Date 12/09/2025
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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