The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink Disposable Concentric Stimulating Probe.
| Device ID | K132138 |
| 510k Number | K132138 |
| Device Name: | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE |
| Classification | Neurosurgical Nerve Locator |
| 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 | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2014-04-11 |
| Summary: | summary |