The following data is part of a premarket notification filed by Top-rank Health Care Equipment Co., Ltd. with the FDA for Adhesive Electrodes.
Device ID | K132588 |
510k Number | K132588 |
Device Name: | ADHESIVE ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
Contact | Diana Hong |
Correspondent | Diana Hong TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-19 |
Decision Date | 2013-11-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20816924020697 | K132588 | 000 |
05060217493588 | K132588 | 000 |
00810038630038 | K132588 | 000 |
00810038630052 | K132588 | 000 |
00850253007161 | K132588 | 000 |
00850253007178 | K132588 | 000 |
10850253007786 | K132588 | 000 |
00858058005030 | K132588 | 000 |
20816924020680 | K132588 | 000 |
10810038636129 | K132588 | 000 |