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FDA 510(k), K200776, Eko CORE
FDA 510(k), K200776, Eko CORE
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510(K) Number: K200776
Device Name: Eko CORE
Manufacturer: Eko Devices, Inc.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 03/25/2020
Decision Date: 04/06/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Eko CORE
Manufacturer: Eko Devices, Inc.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 03/25/2020
Decision Date: 04/06/2020
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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