FDA.reportPublic FDA data

510(k) K233609

Device
CORE 500 Digital Stethoscope
Applicant
Eko Health, Inc.
510(k) number
K233609
Product code
DQD
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-28
Date received
2023-11-13
Regulation
870.1875
Classification name
Stethoscope, Electronic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sam Huang
Address
2100 Powell St. Suite 300 Emeryville CA US 94608 94608

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252915AiSteth®Ai Health Highway India Pvt., Ltd.2026-05-22
K252089Tyto Stethoscope (G3)Tyto Care , Ltd.2026-03-12
K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.2026-02-06
K252284eMurmur Heart AICsd Labs2025-12-19
K252595Stethophone ProSparrow Acoustics, Inc.2025-09-12
K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.2025-08-12
K242971AccurSound Electronic Stethoscope (AS101)Heroic Faith International , Ltd.2024-11-25
K240901StethophoneSparrow Acoustics, Inc.2024-09-19
K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.2024-04-10
K231551StethophoneSparrow Acoustics, Inc.2023-10-12
K230613SKEEPERSmartsound Corporation2023-08-02
K230823AusculThing ACCAusculthing OY2023-07-12
K230111CORE 500 Digital StethoscopeEko Devices, Inc.2023-05-26
K230769PrevisEA DeviceEntac Medical, Inc.2023-05-19
K223785N9+Nonagon , Ltd.2023-04-14