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Comet-PLUS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172711

by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)

Identifiers

510(k) Number: K172711 FDA 510(k)
FDA Product Code: OLV FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.1400 FDA 510(k)
Regulation Number: 882.1400 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Comet-PLUS by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)
FDA Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Sources (1)

FDA 510(k) K172711 24 fields · synced Jun 19, 2026