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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 K250625
Device Name Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
Applicant
Nanjing Yinuoji Medical Technology Co., Ltd.
Rm. 207, 2nd Floor, Bldg. B, #95 Xingangwan Rd.
Longchi St., Luhe District
Nanjing,  CN 210036
Applicant Contact Xiao Xu
Correspondent
Imangel Consulting, Inc.
Deerfield Beach,  FL  33442
Correspondent Contact Jerry Sudduth
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/03/2025
Decision Date 08/27/2025
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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