The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd. with the FDA for Jiajian Self-adhesive Electrode.
| Device ID | K090198 |
| 510k Number | K090198 |
| Device Name: | JIAJIAN SELF-ADHESIVE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu, CN 214116 |
| Contact | Doris Dong |
| Correspondent | Doris Dong WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu, CN 214116 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2009-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810011252301 | K090198 | 000 |
| 10885914070762 | K090198 | 000 |
| 10885914070755 | K090198 | 000 |
| 20885914070745 | K090198 | 000 |
| 20885914070738 | K090198 | 000 |