The following data is part of a premarket notification filed by Chip Ideas Electronics S.l with the FDA for Ekuore One Electronic Interface For Stethoscope.
Device ID | K181882 |
510k Number | K181882 |
Device Name: | EKuore One Electronic Interface For Stethoscope |
Classification | Stethoscope, Electronic |
Applicant | Chip Ideas Electronics S.L Calle Clariano 8, Entresuelo B Valencia, ES 46021 |
Contact | Bernardo Plaza Trujillo |
Correspondent | Bernardo Plaza Trillo Chip Ideas Electronics S.L Calle Clariano 8, Entresuelo B Valencia, ES 46021 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-13 |
Decision Date | 2019-03-27 |