510(k) K242930

Natus BrainWatch System by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Product Code OMC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 19, 2024
Date Received: September 24, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Reduced- Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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