FDA 510(k), K190764, SurgicalAR
FDA 510(k), K190764, SurgicalAR
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510(K) Number: K190764
Device Name: SurgicalAR
Manufacturer: MEDIVIS, Inc.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 03/25/2019
Decision Date: 05/13/2019
Regulation Medical Specialty: Radiology
Device Name: SurgicalAR
Manufacturer: MEDIVIS, Inc.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 03/25/2019
Decision Date: 05/13/2019
Regulation Medical Specialty: Radiology
- 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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