The following data is part of a premarket notification filed by Coapt, Llc with the FDA for Dome Electrode.
| Device ID | K190416 |
| 510k Number | K190416 |
| Device Name: | Dome Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Coapt, LLC 222 W. Ontario Street, Unit #300 Chicago, IL 60654 |
| Contact | Blair Lock |
| Correspondent | Blair Lock Coapt, LLC 222 W. Ontario Street, Unit #300 Chicago, IL 60654 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B618E0 | K190416 | 000 |
| B618P1 | K190416 | 000 |