Pulse Oximeter

Oximeter

Shenzhen Aeon Technology Co., Ltd.

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

Pre-market Notification Details

Device IDK200414
510k NumberK200414
Device Name:Pulse Oximeter
ClassificationOximeter
Applicant Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong No.133 Of Yiyuan Road, Nantou Street, Nanshan District Shenzhen,  CN 518000
ContactXie Hua
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen,  CN 518067
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-19
Decision Date2020-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
36947832500429 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500429 K200414 000
36947832500399 K200414 000
36947832500399 K200414 000

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