The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Mr Conditional Cup Electrode, Mr Conditional Webb Electrode.
| Device ID | K172503 |
| 510k Number | K172503 |
| Device Name: | MR Conditional Cup Electrode, MR Conditional Webb Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 |
| Contact | Daniel Mccoy |
| Correspondent | Daniel Mccoy Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2017-12-01 |
| Summary: | summary |