FDA 510(k), K090019, NATUS NEUROWORKS, MODEL 104196

FDA 510(k), K090019, NATUS NEUROWORKS, MODEL 104196

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510(K) Number: K090019
Device Name: NATUS NEUROWORKS, MODEL 104196
Manufacturer: NATUS MEDICAL, INC.
Device Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 01/02/2009
Decision Date: 02/22/2010
Regulation Medical Specialty: Neurology
  • 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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