The following data is part of a premarket notification filed by Xian Friendship Electronics Co.,ltd. with the FDA for Subdermal Needle Electrodes.
| Device ID | K072276 |
| 510k Number | K072276 |
| Device Name: | SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| Applicant | XIAN FRIENDSHIP ELECTRONICS CO.,LTD. RM 1606 BLDG. 1, JIANXIANG YUA NO. 229 BEI SI HUAN ZHONG RD. Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan XIAN FRIENDSHIP ELECTRONICS CO.,LTD. RM 1606 BLDG. 1, JIANXIANG YUA NO. 229 BEI SI HUAN ZHONG RD. Haidian District, Beijing, CN 100083 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-15 |
| Decision Date | 2008-05-16 |
| Summary: | summary |