The following data is part of a premarket notification filed by Shenzhen Quality Medical Technology Co.,ltd with the FDA for Adhesive Electrodes.
Device ID | K171381 |
510k Number | K171381 |
Device Name: | Adhesive Electrodes |
Classification | Electrode, Cutaneous |
Applicant | ShenZhen Quality Medical Technology Co.,Ltd 5/F, Plant C3, No.1, Nuclear Power Industrial Zone Guanlan Shijing Community Shenzhen, CN |
Contact | Grace Zhao |
Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-11 |
Decision Date | 2017-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860074002245 | K171381 | 000 |
00810025923839 | K171381 | 000 |
00810025923822 | K171381 | 000 |
00850033118148 | K171381 | 000 |
00850033118131 | K171381 | 000 |