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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 K191088
Device Name Checkme O2 Pulse Oximeter
Applicant
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tinwei Industrial Park, No.6, Liufang Rd
Block 67, Xin'an Street
Baoan District Guandong,  CN 518101
Applicant Contact Zhou Saixin
Correspondent
mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/24/2019
Decision Date 12/02/2019
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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