OLYMPIC BRAINZ MONITOR— 510(k) K123079

Substantially Equivalent

Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K123079 for OLYMPIC BRAINZ MONITOR, Substantially Equivalent on 2013-05-08. Applicant: Excel-Tech Ltd. (Xltek).

Clearance details

Applicant: Excel-Tech Ltd. (Xltek)
Product code: Code OMA
Advisory panel: Neurology
Date received: 2012-10-01
Decision date: 2013-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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