Background Pattern Classification [BPc(TM)]— 510(k) K152301

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K152301 for Background Pattern Classification [BPc(TM)], Substantially Equivalent on 2016-06-03. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code OMA
Advisory panel: Neurology
Date received: 2015-08-14
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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