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FDA 510(k), K180021, Proton Positioing and Immobilization Devices
FDA 510(k), K180021, Proton Positioing and Immobilization Devices
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510(K) Number: K180021
Device Name: Proton Positioing and Immobilization Devices
Manufacturer: Alena Newgren
Device Classification Name: Accelerator, Linear, Medical
Regulation Number: IYE
Classification Product Code: 01/03/2018
Date Received: 06/29/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Proton Positioing and Immobilization Devices
Manufacturer: Alena Newgren
Device Classification Name: Accelerator, Linear, Medical
Regulation Number: IYE
Classification Product Code: 01/03/2018
Date Received: 06/29/2018
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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