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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 K163135
Device Name Finger Pulse Oximeter
Applicant
Shenzhen Fitfaith Technology Co.,Ltd
Area B, Floor 9, Bldg. D1, Tangwei Industrial Park,
Donglong Rd.
Guangming New District, Shenzhen,  CN 518000
Applicant Contact Yuan Junfeng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#, Internation Mayor Communication Center,
Baishizhong Rd. 55#,
Nanshan District, Shenzhen,  CN 518000
Correspondent Contact Migo. Yang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/08/2016
Decision Date 09/19/2017
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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