The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Emg Recording Electrode Assembly.
| Device ID | K120342 |
| 510k Number | K120342 |
| Device Name: | EMG RECORDING ELECTRODE ASSEMBLY |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST ST. SOUTH Columbia, SC 29209 |
| Contact | James Mewborne |
| Correspondent | James Mewborne RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST ST. SOUTH Columbia, SC 29209 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-06-22 |