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FDA 510(k), K213794, Eko Murmur Analysis Software (EMAS)
FDA 510(k), K213794, Eko Murmur Analysis Software (EMAS)
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510(K) Number: K213794
Device Name: Eko Murmur Analysis Software (EMAS)
Manufacturer: Sam Huang
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 12/06/2021
Date Received: 06/29/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Eko Murmur Analysis Software (EMAS)
Manufacturer: Sam Huang
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 12/06/2021
Date Received: 06/29/2022
Decision Date: Substantially Equivalent (SESE)
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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