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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Oximeter
510(k) Number K191430
Device Name Pulse Oximeter
Applicant
Shenzhen Yimi Life-Technology Co., Ltd.
305 Tengbo Industrial Park, Changshangjiang St.,
Longbei Village, Pingshan
Shenzhen,  CN 518118
Applicant Contact Shande Peng
Correspondent
Shenzhen Yimi Life-Technology Co., Ltd.
305 Tengbo Industrial Park, Changshangjiang St.,
Longbei Village, Pingshan
Shenzhen,  CN 518118
Correspondent Contact Shande Peng
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/29/2019
Decision Date 10/18/2019
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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