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FDA 510(k), K172035, EKOS ultrasound EVD Device, EVD Control Unit
FDA 510(k), K172035, EKOS ultrasound EVD Device, EVD Control Unit
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510(K) Number: K172035
Device Name: EKOS ultrasound EVD Device, EVD Control Unit
Manufacturer: Brit Baird
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: KXA
Date Received: 07/05/2017
Decision Date: 03/24/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: EKOS ultrasound EVD Device, EVD Control Unit
Manufacturer: Brit Baird
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: KXA
Date Received: 07/05/2017
Decision Date: 03/24/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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