The following data is part of a premarket notification filed by Nanjing Eco Microwave System Co., Ltd with the FDA for Microwave Therapeutic System.
| Device ID | K201262 |
| 510k Number | K201262 |
| Device Name: | Microwave Therapeutic System |
| Classification | System, 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 |
| Contact | Hong Wei |
| Correspondent | Hong Wei Nanjing ECO Microwave System Co., Ltd Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing, CN 211800 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2021-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972405777006 | K201262 | 000 |