Kubtec Mozart (Xpert42)— 510(k) K183624

Substantially Equivalent

Kub Technologies, Inc.

FDA 510(k) clearance K183624 for Kubtec Mozart (Xpert42), Substantially Equivalent on 2019-06-20. Applicant: Kub Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kub Technologies, Inc.
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2018-12-26
Decision date: 2019-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stratford, CT, US

Download summary PDF View on FDA.gov ↗

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