The following data is part of a premarket notification filed by Xian Friendship Medical Electronics Co., Ltd. with the FDA for Friendship Medical Disposable Pre-gelled Ag / Agcl Surface Electrode.
| Device ID | K110289 |
| 510k Number | K110289 |
| Device Name: | FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. NO 9, GAO ZIN 1ST ROAD HI-TECH DEVELOPMENT ZONE Xi'an, Shaanxi, CN 710075 |
| Contact | Zhai Ying Chuan |
| Correspondent | Zhai Ying Chuan XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. NO 9, GAO ZIN 1ST ROAD HI-TECH DEVELOPMENT ZONE Xi'an, Shaanxi, CN 710075 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-08-30 |
| Summary: | summary |