Disposable Microwave Therapeutic Antennas

System, Ablation, Microwave And Accessories

Nanjing ECO Microwave System Co., Ltd.

The following data is part of a premarket notification filed by Nanjing Eco Microwave System Co., Ltd. with the FDA for Disposable Microwave Therapeutic Antennas.

Pre-market Notification Details

Device IDK201265
510k NumberK201265
Device Name:Disposable Microwave Therapeutic Antennas
ClassificationSystem, Ablation, Microwave And Accessories
Applicant Nanjing ECO Microwave System Co., Ltd. Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing,  CN 211800
ContactHong Wei
CorrespondentHong Wei
Nanjing ECO Microwave System Co., Ltd. Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing,  CN 211800
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2021-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06972405777211 K201265 000
06972405777099 K201265 000
06972405777082 K201265 000
06972405777075 K201265 000
06972405777068 K201265 000
06972405777051 K201265 000
06972405777044 K201265 000
06972405777037 K201265 000
06972405777020 K201265 000
06972405777105 K201265 000
06972405777112 K201265 000
06972405777129 K201265 000
06972405777204 K201265 000
06972405777198 K201265 000
06972405777181 K201265 000
06972405777174 K201265 000
06972405777167 K201265 000
06972405777150 K201265 000
06972405777143 K201265 000
06972405777136 K201265 000
06972405777013 K201265 000

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