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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 K203812
Device Name Oxyfit Pulse Oximeter
Applicant
Shenzhen Viatom Technology Co., Ltd.
4e, Bldg. 3, Tingwei Industrial Park, #6 Liufang Rd.
Block 67, Xin’An St., Baoan District, 5
Shenzhen,  CN 518101
Applicant Contact Zhou Saixin
Correspondent
Shenzhen Viatom Technology Co., Ltd.
4e, Bldg. 3, Tingwei Industrial Park, #6 Liufang Rd.
Block 67, Xin’An St., Baoan District, 5
Shenzhen,  CN 518101
Correspondent Contact Weifeng Tao
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/28/2020
Decision Date 11/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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