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 |