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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K260931
Device Name Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan D
Shenzhen,  CN 518108
Applicant Contact Huanyu Zeng
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan D
Shenzhen,  CN 518108
Correspondent Contact Huanyu Zeng
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/20/2026
Decision Date 04/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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