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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 K170965
Device Name Fingertip Pulse Oximeter
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
Jumper Building, No.71-4, Xintian Avenue, Fuyong Street
Baoan District, Shenzhen,  CN 518103
Applicant Contact Yang Gang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#,International Mayor Communication Center
Baishizhong Road 55#
Nanshan District, Shenzhen,  CN 518000
Correspondent Contact Migo Yang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/31/2017
Decision Date 11/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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