510(k) K212013

eKuore Pro 4T - REF EP0098 by Chip Ideas Electronics S.L. — Product Code DQD

K212013 is an FDA 510(k) premarket notification submitted by Chip Ideas Electronics S.L. for the device "eKuore Pro 4T - REF EP0098". The FDA issued a decision of Substantially Equivalent on Nov 10, 2021. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Chip Ideas Electronics S.L. has 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 10, 2021
Date Received
Jun 28, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Electronic
Device Class
Class II
Regulation Number
870.1875
Review Panel
CV
Submission Type
510(k)