The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Mr Conditional Presson Electrode.
| Device ID | K130220 |
| 510k Number | K130220 |
| Device Name: | MR CONDITIONAL PRESSON ELECTRODE |
| Classification | Electrode, Needle |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Contact | James M Mewborne |
| Correspondent | James M Mewborne RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-07-22 |
| Summary: | summary |