510(k) K181882

eKuore One electronic interface for stethoscope by Chip Ideas Electronics S.L. — Product Code DQD

K181882 is an FDA 510(k) premarket notification submitted by Chip Ideas Electronics S.L. for the device "eKuore One electronic interface for stethoscope". The FDA issued a decision of Substantially Equivalent on Mar 27, 2019. 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
Mar 27, 2019
Date Received
Jul 13, 2018
Clearance Type
Traditional
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)