The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Presson Electrode Headset.
| Device ID | K190801 |
| 510k Number | K190801 |
| Device Name: | PressOn Electrode Headset |
| Classification | Electrode, Needle |
| Applicant | Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 |
| Contact | Gabriel Orsinger |
| Correspondent | Gabriel Orsinger Rhythmlink International, LLC 1140 First Street South Columbia, SC 29209 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816312023077 | K190801 | 000 |