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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 K230277
Device Name Pulse Oximeter(Model OHT60,OXH78)
Cofoe Medical Technology Co., Ltd.
No.87, Section 1, East Huanbao Road, Yuhua District
Changsha,  CN 410000
Applicant Contact Yang Cui
Shanghai Truthful Information Technology Co., Ltd.
RM.1801,No.161,East Lujiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.2700
Classification Product Code
Date Received02/01/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No