The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink International Subdermal Needle Electrodes.
| Device ID | K022914 |
| 510k Number | K022914 |
| Device Name: | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 2013 WINDSOR DR. Cayce, SC 29033 |
| Contact | Brett L Netherton |
| Correspondent | Brett L Netherton RHYTHMLINK INTERNATIONAL, LLC 2013 WINDSOR DR. Cayce, SC 29033 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-12-20 |
| Summary: | summary |