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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K253964
Device Name Disposable Neonatal NIBP Cuff (U1681S-C51N)
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou
Shiyan, Baoan District
Shenzhen,  CN 518108
Applicant Contact Huanyu Zeng
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou
Shiyan, Baoan District
Shenzhen,  CN 518108
Correspondent Contact Huanyu Zeng
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/11/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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