CORE 500 Digital Stethoscope— 510(k) K230111
Substantially EquivalentEko Devices, Inc.
FDA 510(k) clearance K230111 for CORE 500 Digital Stethoscope, Substantially Equivalent on 2023-05-26. Applicant: Eko Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Eko Devices, Inc.
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, US
Recent devices under product code DQD
view allMore clearances from Eko Devices, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.