The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink Monopolar Stimulating Instrument.
| Device ID | K112435 |
| 510k Number | K112435 |
| Device Name: | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT |
| Classification | Stimulator, Nerve |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Contact | James Mewborne |
| Correspondent | James Mewborne RHYTHMLINK INTERNATIONAL, LLC 1140 FIRST STREET SOUTH Columbia, SC 29209 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-09-22 |
| Summary: | summary |