Eko Murmur Analysis Software (EMAS)
510(k) K213794
Eko Murmur Analysis Software (EMAS) is a Class II device made by Eko Devices, Inc., cleared under FDA 510(k) K213794 on 29 Jun 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213794 | Date29 Jun 2022 | StatusActive |
Official records
- FDA 510(k) database K213794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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