Eko Electronic Stethoscope System— 510(k) K151319
Substantially EquivalentEko Devices, Inc.
FDA 510(k) clearance K151319 for Eko Electronic Stethoscope System, Substantially Equivalent on 2015-08-28. 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
- Berkeley, CA, US
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