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

Name: FDA 510(k) clearance K152301
Creator: U.S. Food and Drug Administration
Published: 2016-06-03

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). Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2015-08-14
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.