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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 K252827
Device Name IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
Applicant
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
Luebeck,  DE 23542
Applicant Contact Jan Upmeier
Correspondent
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
Luebeck,  DE 23542
Correspondent Contact Jan Upmeier
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/05/2025
Decision Date 12/01/2025
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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