The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink International Monopolar Stimulating Instrument.
| Device ID | K072736 |
| 510k Number | K072736 |
| Device Name: | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT |
| Classification | Stimulator, Nerve |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 1256 FIRST ST. SOUTH EXTENSION Columbia, SC 29209 |
| Contact | James Mewborne |
| Correspondent | James Mewborne RHYTHMLINK INTERNATIONAL, LLC 1256 FIRST ST. SOUTH EXTENSION Columbia, SC 29209 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2008-01-22 |
| Summary: | summary |