The following data is part of a premarket notification filed by Reno Medical Limited with the FDA for Adhesive Electrodes.
Device ID | K102842 |
510k Number | K102842 |
Device Name: | ADHESIVE ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | RENO MEDICAL LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
Contact | Diana Hong |
Correspondent | Diana Hong RENO MEDICAL LIMITED P.O. BOX 237-023 Shanghai, CN 200237 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-29 |
Decision Date | 2010-12-02 |