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FDA 510(k)

TrueView 100 Pro

K-Number: K202713 · 2020-11-18

ApplicantCompai Healthcare (Shenzhen) Co.,Ltd
Decision Date2020-11-18
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueView 100 Pro is the device name listed in this FDA 510(k) record. The listed applicant is Compai Healthcare (Shenzhen) Co.,Ltd. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202713. 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 TrueView 100 Pro?

TrueView 100 Pro is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Compai Healthcare (Shenzhen) Co.,Ltd. The 510(k) number is K202713.

When did TrueView 100 Pro receive FDA 510(k) clearance?

TrueView 100 Pro received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202713.

Who is the listed applicant for TrueView 100 Pro?

The FDA 510(k) record lists Compai Healthcare (Shenzhen) Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueView 100 Pro?

The FDA product code for TrueView 100 Pro is MWP.

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.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.

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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