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FDA 510(k), K161237, HyperView Hyperspectral Tissue Oxygenation Measurement System
FDA 510(k), K161237, HyperView Hyperspectral Tissue Oxygenation Measurement System
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510(K) Number: K161237
Device Name: HyperView Hyperspectral Tissue Oxygenation Measurement System
Manufacturer: Carlyn Reynolds
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 05/02/2016
Date Received: 12/16/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: HyperView Hyperspectral Tissue Oxygenation Measurement System
Manufacturer: Carlyn Reynolds
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 05/02/2016
Date Received: 12/16/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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