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FDA 510(k), K133355, CADWELL FLEX EEG/PSG
FDA 510(k), K133355, CADWELL FLEX EEG/PSG
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510(K) Number: K133355
Device Name: CADWELL FLEX EEG/PSG
Manufacturer: CADWELL INDUSTRIES, INC.
Device Classification Name: full-montage standard electroencephalograph
Regulation Number: 882.1400
Classification Product Code: GWQ
Date Received: 10/31/2013
Decision Date: 01/29/2014
Regulation Medical Specialty: Neurology
Device Name: CADWELL FLEX EEG/PSG
Manufacturer: CADWELL INDUSTRIES, INC.
Device Classification Name: full-montage standard electroencephalograph
Regulation Number: 882.1400
Classification Product Code: GWQ
Date Received: 10/31/2013
Decision Date: 01/29/2014
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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