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 |