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FDA 510(k), K061916, NEURO II-SE, MODELS OR-MB-DR AND OR-DR
FDA 510(k), K061916, NEURO II-SE, MODELS OR-MB-DR AND OR-DR
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510(K) Number: K061916
Device Name: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Manufacturer: IMRIS, INC.
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 07/06/2006
Decision Date: 08/11/2006
Regulation Medical Specialty: Radiology
Device Name: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Manufacturer: IMRIS, INC.
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 07/06/2006
Decision Date: 08/11/2006
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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