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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K253166
Device Name F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
Applicant
BMC Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plz., # 16 Lize Rd.
Fengtai District
Beijing,  CN 100073
Applicant Contact Nicole Niu
Correspondent
BMC Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plz., # 16 Lize Rd.
Fengtai District
Beijing,  CN 100073
Correspondent Contact Nicole Niu
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/26/2025
Decision Date 04/29/2026
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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