The following data is part of a premarket notification filed by Chip Ideas Electronics S.l. with the FDA for Ekuore Pro 4t - Ref Ep0098.
| Device ID | K212013 |
| 510k Number | K212013 |
| Device Name: | EKuore Pro 4T - REF EP0098 |
| Classification | Stethoscope, Electronic |
| Applicant | Chip Ideas Electronics S.L. C/ Alfareria 3 B Burjasot, ES 46100 |
| Contact | Bernardo Plaza Trillo |
| Correspondent | Bernardo Plaza Trillo Chip Ideas Electronics S.L. C/ Alfareria 3 B Burjasot, ES 46100 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-11-10 |