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FDA 510(k), K201188, Clear Guide SCENERGY
FDA 510(k), K201188, Clear Guide SCENERGY
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510(K) Number: K201188
Device Name: Clear Guide SCENERGY
Manufacturer: Clear Guide Medical
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 05/01/2020
Decision Date: 09/30/2020
Regulation Medical Specialty: Radiology
Device Name: Clear Guide SCENERGY
Manufacturer: Clear Guide Medical
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 05/01/2020
Decision Date: 09/30/2020
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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