Comet-PLUS— 510(k) K172711

Substantially Equivalent

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

FDA 510(k) clearance K172711 for Comet-PLUS, Substantially Equivalent on 2017-11-03. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code OLV
Advisory panel: Neurology
Date received: 2017-09-08
Decision date: 2017-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, CA

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