The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co., Ltd with the FDA for Electrodes With Snap / Electrodes With Pigtail.
Device ID | K171722 |
510k Number | K171722 |
Device Name: | Electrodes With Snap / Electrodes With Pigtail |
Classification | Electrode, Cutaneous |
Applicant | Shenzhen Konmed Technology Co., Ltd 703B, Haide Building A, Nanxin Road, Nanshan Shenzhen, CN 518000 |
Contact | Tony Tony |
Correspondent | Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510006 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-12 |
Decision Date | 2018-01-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970935830161 | K171722 | 000 |
06970935830154 | K171722 | 000 |
06970935830116 | K171722 | 000 |
06970935830109 | K171722 | 000 |
06970935830093 | K171722 | 000 |
06970935830086 | K171722 | 000 |
06970935830079 | K171722 | 000 |