The following data is part of a premarket notification filed by Chip Ideas Electronics S.l. with the FDA for Ekuore Pro Series.
Device ID | K203007 |
510k Number | K203007 |
Device Name: | EKuore Pro Series |
Classification | Stethoscope, Electronic |
Applicant | Chip Ideas Electronics S.L. Calle Alfareria 3 B Burjasot, ES 46100 |
Contact | Bernardo Plaza Trillo |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2020-10-01 |
Decision Date | 2020-10-30 |