The following data is part of a premarket notification filed by Beijing Jinhengwei Technology Development Co., Ltd with the FDA for Electrosurgical Generator.
| Device ID | K130760 |
| 510k Number | K130760 |
| Device Name: | ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD NO. 631 XINGONG VILLAGE EAST SIDE OF 2ND FL OF SOUTH BLDG Beijing, CN 100069 |
| Contact | Ligang Mao |
| Correspondent | Ligang Mao BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD NO. 631 XINGONG VILLAGE EAST SIDE OF 2ND FL OF SOUTH BLDG Beijing, CN 100069 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-09-16 |
| Summary: | summary |