The following data is part of a premarket notification filed by Authentic Medical with the FDA for Surelead Cable System.
| Device ID | K181089 |
| 510k Number | K181089 |
| Device Name: | SureLead Cable System |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Authentic Medical 4470 Yankee Hill Rd., Ste 100 Rocklin, CA 95677 |
| Contact | Ricky Souza |
| Correspondent | Ricky Souza Authentic Medical 4470 Yankee Hill Rd., Ste 100 Rocklin, CA 95677 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2020-01-17 |