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FDA 510(k), K190024, Smart-C
FDA 510(k), K190024, Smart-C
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510(K) Number: K190024
Device Name: Smart-C
Manufacturer: Michael Drake
Device Classification Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation Number: OXO
Classification Product Code: 01/07/2019
Date Received: 09/27/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Smart-C
Manufacturer: Michael Drake
Device Classification Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation Number: OXO
Classification Product Code: 01/07/2019
Date Received: 09/27/2019
Decision Date: Substantially Equivalent (SESE)
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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