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FDA 510(k), K191171, EchoGo Core
FDA 510(k), K191171, EchoGo Core
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510(K) Number: K191171
Device Name: EchoGo Core
Manufacturer: Ultromics Ltd
Device Classification Name: automated radiological image processing software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 05/01/2019
Decision Date: 11/13/2019
Regulation Medical Specialty: Radiology
Device Name: EchoGo Core
Manufacturer: Ultromics Ltd
Device Classification Name: automated radiological image processing software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 05/01/2019
Decision Date: 11/13/2019
Regulation Medical Specialty: Radiology
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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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