510(k) K213794
K213794 is an FDA 510(k) premarket notification submitted by Eko Devices, Inc. for the device "Eko Murmur Analysis Software (EMAS)". The FDA issued a decision of Substantially Equivalent on Jun 29, 2022. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Devices, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 2022
- Date Received
- Dec 6, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type
- 510(k)