The following data is part of a premarket notification filed by Coapt, Llc with the FDA for Complete Control System.
| Device ID | K162891 |
| 510k Number | K162891 |
| Device Name: | Complete Control System |
| Classification | Electrode, Cutaneous |
| Applicant | COAPT, LLC 222 WEST ONTARIO STREET UNIT#300 Chicago, IL 60654 |
| Contact | Blair Lock |
| Correspondent | Carrie Hetrick EMERGO GLOBAL CONSULTING, LLC 2500 BEE CAVE ROAD BUILDING 1, SUITE 300 Austin, TX 78746 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B618D0 | K162891 | 000 |
| B618C0 | K162891 | 000 |
| B618B0 | K162891 | 000 |
| B618A0 | K162891 | 000 |