Finger Pulse Oximeter

Oximeter

SHENZHEN FITFAITH TECHNOLOGY CO.,LTD

The following data is part of a premarket notification filed by Shenzhen Fitfaith Technology Co.,ltd with the FDA for Finger Pulse Oximeter.

Pre-market Notification Details

Device IDK163135
510k NumberK163135
Device Name:Finger Pulse Oximeter
ClassificationOximeter
Applicant SHENZHEN FITFAITH TECHNOLOGY CO.,LTD AREA B, FLOOR 9, BUILDING D1, TANGWEI INDUSTRIAL PARK, DONGLONG RD Guangming New District, Shenzhen,  CN 518000
ContactYuan Junfeng
CorrespondentMigo. Yang
Shenzhen Joyantech Consulting Co., Ltd. 1122#, INTERNATION MAYOR COMMUNICATION CENTER, BAISHIZHONG RD 55#, Nanshan District, Shenzhen,  CN 518000
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-08
Decision Date2017-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970953261305 K163135 000
06970953261107 K163135 000
06970953260049 K163135 000
06970953260032 K163135 000
06970953260025 K163135 000
00851457007285 K163135 000
20815991022634 K163135 000

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