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FDA 510(k), K220766, eMurmur Heart AI
FDA 510(k), K220766, eMurmur Heart AI
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510(K) Number: K220766
Device Name: eMurmur Heart AI
Manufacturer: Andreas Reinisch
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 03/16/2022
Date Received: 05/31/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: eMurmur Heart AI
Manufacturer: Andreas Reinisch
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: 03/16/2022
Date Received: 05/31/2022
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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