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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 K251045
Device Name Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan
District
Shenzhen,  CN
Applicant Contact Huanyu Zeng
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan
District
Shenzhen,  CN
Correspondent Contact Huanyu Zeng
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received04/03/2025
Decision Date 07/15/2025
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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