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 |