The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink Disposable Concentric Emg Needle, Model D039032252r.
| Device ID | K091055 |
| 510k Number | K091055 |
| Device Name: | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1256 FIRST ST. SOUTH EXTENSION Columbia, SC 29209 |
| Contact | James M Mewborne |
| Correspondent | James M Mewborne RHYTHMLINK INTERNATIONAL, LLC 1256 FIRST ST. SOUTH EXTENSION 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 | 2009-04-13 |
| Decision Date | 2009-06-23 |
| Summary: | summary |