The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd with the FDA for Jaijian Self-adhesive Electrode.
Device ID | K192568 |
510k Number | K192568 |
Device Name: | Jaijian Self-Adhesive Electrode |
Classification | Electrode, Cutaneous |
Applicant | Wuxi Jiajian Medical Instrument Co., Ltd NO.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, CN 214116 |
Contact | Caihong Sun |
Correspondent | Caihong Sun Wuxi Jiajian Medical Instrument Co., Ltd NO.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, CN 214116 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-18 |
Decision Date | 2021-02-03 |