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FDA 510(k)

Kubtec Mozart (XPERT42)

K-Number: K210956 · 2021-08-31

ApplicantKub Technologies, Inc.
Decision Date2021-08-31
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kubtec Mozart (XPERT42) is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210956. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kubtec Mozart (XPERT42)?

Kubtec Mozart (XPERT42) is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210956.

When did Kubtec Mozart (XPERT42) receive FDA 510(k) clearance?

Kubtec Mozart (XPERT42) received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210956.

Who is the listed applicant for Kubtec Mozart (XPERT42)?

The FDA 510(k) record lists Kub Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kubtec Mozart (XPERT42)?

The FDA product code for Kubtec Mozart (XPERT42) is MWP.

Other records listing Kub Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemK210957Kubec Xpert 80 Radiography SystemK200756Kubtec Mozart SupraK183624Kubtec Mozart (Xpert42)

Related Devices (Code: MWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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