510(k) K201742

eKuore One Wireless Electronic Interface for stethoscope by Chip Ideas Electronics S.L. — Product Code DQD

K201742 is an FDA 510(k) premarket notification submitted by Chip Ideas Electronics S.L. for the device "eKuore One Wireless Electronic Interface for stethoscope". The FDA issued a decision of Substantially Equivalent on Nov 24, 2020. 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 24, 2020
Date Received
Jun 25, 2020
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)