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510(k) K171414

qEEG-Pro by Brainmaster Technologies, Inc. — Product Code OLU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2018
Date Received
May 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

Other clearances by Brainmaster Technologies, Inc.

  • K150498 — Discovery 24 (January 26, 2016)

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  • K112077 — HBIDB - HUMAN BRIAN INDEX SOFTWARE (March 9, 2012)
  • K050192 — BRC SOFTWARE PRODUCT (October 20, 2005)
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