FDA 510(k), K161112, KARL STORZ Flexible Video-Neuro-Endoscope System
FDA 510(k), K161112, KARL STORZ Flexible Video-Neuro-Endoscope System
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510(K) Number: K161112
Device Name: KARL STORZ Flexible Video-Neuro-Endoscope System
Manufacturer: SUSIE S. CHEN
Device Classification Name: Endoscope, Neurological
Regulation Number: GWG
Classification Product Code: 04/20/2016
Date Received: 09/17/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: KARL STORZ Flexible Video-Neuro-Endoscope System
Manufacturer: SUSIE S. CHEN
Device Classification Name: Endoscope, Neurological
Regulation Number: GWG
Classification Product Code: 04/20/2016
Date Received: 09/17/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- 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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