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U.S. Department of Health and Human Services

Devices@FDA
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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 Street,
Longbei Village, Pingshan
Shenzhen,  CN 518118
Applicant Contact Shande Peng
Correspondent
Shenzhen Yimi Life-Technology Co.,Ltd.
305 Tengbo Industrial Park, Changshangjiang Street,
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
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