The following data is part of a premarket notification filed by Top-rank Health Care Equipment Co., Ltd. with the FDA for Top-rank Adhesive Electrode.
Device ID | K070612 |
510k Number | K070612 |
Device Name: | TOP-RANK ADHESIVE ELECTRODE |
Classification | Electrode, Cutaneous |
Applicant | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. DONGGUAN ST. Shangyu City, CN 312352 |
Contact | Uwe Degenhardt |
Correspondent | Laura Danielson TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-03-05 |
Decision Date | 2007-05-07 |