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FDA 510(k), K010817, MX8000 V5.0 CT SYSTEM
FDA 510(k), K010817, MX8000 V5.0 CT SYSTEM
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510(K) Number: K010817
Device Name: MX8000 V5.0 CT SYSTEM
Manufacturer: ROBERT L TUROCY
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 03/19/2001
Date Received: 06/15/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: MX8000 V5.0 CT SYSTEM
Manufacturer: ROBERT L TUROCY
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 03/19/2001
Date Received: 06/15/2001
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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