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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 Bldg., #71-4, Xintian Ave., Fuyong St.
Baoan District, Shenzhen,  CN 518103
Applicant Contact Yang Gang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#, International Mayor Communication Center,
Baishizhong Rd. 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
Predetermined Change
Control Plan Authorized		 No
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