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FDA 510(k), K191301, Ceribell Pocket EEG Device
FDA 510(k), K191301, Ceribell Pocket EEG Device
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510(K) Number: K191301
Device Name: Ceribell Pocket EEG Device
Manufacturer: Ceribell, Inc.
Device Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 05/14/2019
Decision Date: 09/11/2019
Regulation Medical Specialty: Neurology
Device Name: Ceribell Pocket EEG Device
Manufacturer: Ceribell, Inc.
Device Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 05/14/2019
Decision Date: 09/11/2019
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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