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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 K251691
Device Name Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
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 Number870.2700
Classification Product Code
DQA  
Date Received06/02/2025
Decision Date 12/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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