510(k) K233313

Keikku Electronic stethoscope by Lapsi Health Holding B.V. — Product Code DQD

K233313 is an FDA 510(k) premarket notification submitted by Lapsi Health Holding B.V. for the device "Keikku Electronic stethoscope". The FDA issued a decision of Substantially Equivalent on April 10, 2024. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2024
Date Received
September 29, 2023
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