The following data is part of a premarket notification filed by Baisheng Medical Co.,ltd. with the FDA for Obs Electrosurgical Generator (model: Obs-350a).
| Device ID | K162034 |
| 510k Number | K162034 |
| Device Name: | OBS Electrosurgical Generator (Model: OBS-350A) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Baisheng Medical Co.,Ltd. No.11 Fusheng Road, Xinhui District Jiangmen, CN 529100 |
| Contact | Peter Mao |
| Correspondent | Albert T.w. Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu, TW |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-01-30 |
| Summary: | summary |