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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.
Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road
Fengtai District
Beijing,  CN 100073
Applicant Contact Amy Wang
Correspondent
BMC Medical Co., Ltd.
Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road
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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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