Microwave Therapeutic System

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 Microwave Therapeutic System.

Pre-market Notification Details

Device IDK201262
510k NumberK201262
Device Name:Microwave Therapeutic System
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 Date2021-07-09

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