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FDA 510(k), K182616, NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
FDA 510(k), K182616, NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
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510(K) Number: K182616
Device Name: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
Manufacturer: Eman Namati
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: 09/21/2018
Date Received: 11/02/2018
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
Manufacturer: Eman Namati
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: 09/21/2018
Date Received: 11/02/2018
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: General & Plastic Surgery
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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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