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 IDK190869
510k NumberK190869
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 518052
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 Received2019-04-03
Decision Date2019-09-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
36947832500375 K190869 000
08719699634480 K190869 000
46947832500372 K190869 000
36947832500085 K190869 000
36947832500108 K190869 000
36947832500115 K190869 000
36947832500122 K190869 000
36947832500306 K190869 000
36947832500351 K190869 000
36947832500368 K190869 000
46947832500099 K190869 000

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