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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 K260171
Device Name Portable Oxygen Concentrator (PO1 5B, PO1 6B)
Applicant
BMC Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plz.
# 16 Lize Rd., Fengtai District
Beijing,  CN
Applicant Contact Nicole Niu
Correspondent
BMC Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plz.
# 16 Lize Rd., Fengtai District
Beijing,  CN
Correspondent Contact Nicole Niu
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/21/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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