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FDA 510(k), K143643, Brainscope Ahead 200
FDA 510(k), K143643, Brainscope Ahead 200
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510(K) Number: K143643
Device Name: Brainscope Ahead 200
Manufacturer: Michael E Singer
Device Classification Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Regulation Number: PIW
Classification Product Code: KXA
Date Received: 12/22/2014
Decision Date: 05/15/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Brainscope Ahead 200
Manufacturer: Michael E Singer
Device Classification Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Regulation Number: PIW
Classification Product Code: KXA
Date Received: 12/22/2014
Decision Date: 05/15/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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