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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K251669
Device Name IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter
Applicant
Shanghai Draeger Medical Instrument Co., Ltd.
3#, #229, Hupo Rd. Shanghai International Medical Zone
Shanghai,  CN 201321
Applicant Contact Guozhao Pan
Correspondent
Shanghai Draeger Medical Instrument Co., Ltd.
3#, #229, Hupo Rd. Shanghai International Medical Zone
Shanghai,  CN 201321
Correspondent Contact Guozhao Pan
Regulation Number870.2900
Classification Product Code
DSA  
Date Received05/30/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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