FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORE 500 Digital Stethoscope
K Number: K230111
·
Decision May 26, 2023
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
6
Review Days
129
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CORE 500 Digital Stethoscope
- K Number
- K230111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eko Devices, Inc.
- Date Received
- January 17, 2023
- Decision Date
- May 26, 2023
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQD), ordered by most recent decision date.
AiSteth®
FDA 510(k)
FDA Class 2
·Cardiovascular
Tyto Stethoscope (G3)
FDA 510(k)
FDA Class 2
·Cardiovascular
Kneevoice Cartilage Evaluation System (750-3600-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
eMurmur Heart AI
FDA 510(k)
FDA Class 2
·Cardiovascular
Stethophone Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Eko Foundation Analysis Software with Transformers (EFAST)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Eko Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213794 | Eko Murmur Analysis Software (EMAS) | Jun 29, 2022 | Substantially Equivalent |
| K200776 | Eko CORE | Apr 6, 2020 | Substantially Equivalent |
| K192004 | Eko Analysis Software | Jan 15, 2020 | Substantially Equivalent |
| K170874 | Eko Model E5 System (EME5), Eko DUO | May 19, 2017 | Substantially Equivalent |
| K151319 | Eko Electronic Stethoscope System | Aug 28, 2015 | Substantially Equivalent |