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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 K173045
Device Name Oximeter
Applicant
Shenzhen Greatmade Tech limited
3th floor, B building, BaiFuli Industrial Zone
ShangHengLang, HuaHui Road
Shenzhen,  CN
Applicant Contact Mei Mei
Correspondent
Shenzhen Greatmade Tech limited
3th floor, B building, BaiFuli Industrial Zone
ShangHengLang, HuaHui Road
Shenzhen,  CN
Correspondent Contact Mei Mei
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/28/2017
Decision Date 06/05/2018
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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