The following data is part of a premarket notification filed by Coapt, Llc with the FDA for Complete Control System Gen2.
| Device ID | K191083 |
| 510k Number | K191083 |
| Device Name: | COMPLETE CONTROL System Gen2 |
| Classification | Electrode, Cutaneous |
| Applicant | Coapt, LLC 222 W. Ontario Street, Suite #300 Chicago, IL 60654 |
| Contact | Blair A Lock |
| Correspondent | Blair A Lock Coapt, LLC 222 W. Ontario Street, Suite #300 Chicago, IL 60654 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B618N1 | K191083 | 000 |