TrueView 100 Pro— 510(k) K202713

Name: FDA 510(k) clearance K202713
Creator: U.S. Food and Drug Administration
Published: 2020-11-18

Substantially Equivalent

Compai Healthcare (Shenzhen) Co.,Ltd

FDA 510(k) clearance K202713 for TrueView 100 Pro, Substantially Equivalent on 2020-11-18. Applicant: Compai Healthcare (Shenzhen) Co.,Ltd. Device class: 2.

Clearance details

Applicant: Compai Healthcare (Shenzhen) Co.,Ltd
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-09-16
Decision date: 2020-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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