The following data is part of a premarket notification filed by Reno Medical Ltd. with the FDA for Adhesive Electrodes.
| Device ID | K170744 |
| 510k Number | K170744 |
| Device Name: | Adhesive Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Reno Medical Ltd. MNC2246 RM1007, 10/F, Ho King Comm CTR 2-16Fa Yuen Street, Mongkok Hongkong, CN 999077 |
| Contact | Liming Ren |
| Correspondent | Diana Hong Mid-Link Consulting 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 | 2017-03-10 |
| Decision Date | 2017-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815991021699 | K170744 | 000 |
| 20815991021675 | K170744 | 000 |
| 20815991021668 | K170744 | 000 |