FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Eko CORE
K Number: K200776
·
Decision Apr 6, 2020
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- Eko CORE
- K Number
- K200776
- 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
- March 25, 2020
- Decision Date
- April 6, 2020
- 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 |
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Other Clearances by Eko Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230111 | CORE 500 Digital Stethoscope | May 26, 2023 | Substantially Equivalent |
| K213794 | Eko Murmur Analysis Software (EMAS) | Jun 29, 2022 | 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 |