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.
| Device ID | K201265 |
| 510k Number | K201265 |
| Device Name: | Disposable Microwave Therapeutic Antennas |
| 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 | 2021-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |