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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 K242935
Device Name Respiration Data Management Software (PAP Link PC)
Applicant
Bmc Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plaza, # 16 Lize Rd.
Fengtai District
Beijing,  CN 100073
Applicant Contact Amy Wang
Correspondent
Bmc Medical Co., Ltd.
Rm. 10, 17f, Bldg. 4, Huiya Plaza, # 16 Lize Rd.
Fengtai District
Beijing,  CN 100073
Correspondent Contact Amy Wang
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/25/2024
Decision Date 01/15/2025
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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