The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Cutaneous Electrode.
| Device ID | K052188 |
| 510k Number | K052188 |
| Device Name: | CUTANEOUS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | RHYTHMLINK INTERNATIONAL, LLC 917 BROOKWOOD DR. Columbia, SC 29201 |
| Contact | James M Mewborne |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-08-23 |
| Summary: | summary |