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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 K222213
Device Name Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan
Shenzhen,  CN 518108
Applicant Contact Hui Zhang
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan
Shenzhen,  CN 518108
Correspondent Contact Hui Zhang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/25/2022
Decision Date 12/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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