Checkme O2 Pulse Oximeter

Oximeter

Shenzhen Viatom Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Viatom Technology Co., Ltd. with the FDA for Checkme O2 Pulse Oximeter.

Pre-market Notification Details

Device IDK191088
510k NumberK191088
Device Name:Checkme O2 Pulse Oximeter
ClassificationOximeter
Applicant Shenzhen Viatom Technology Co., Ltd. 4E, Building 3, Tinwei Industrial Park, No.6, Liufang Rd Block 67, Xin'an Street Baoan District Guandong,  CN 518101
ContactZhou Saixin
CorrespondentVaibhav Arvind Rajal
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck,  NY  11021
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-24
Decision Date2019-12-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06934440102601 K191088 000
00817698020681 K191088 000

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