OrthoAnalysis Software— 510(k) K183695

Substantially Equivalent

Inteware Co., Ltd.

FDA 510(k) clearance K183695 for OrthoAnalysis Software, Substantially Equivalent on 2019-09-12. Applicant: Inteware Co., Ltd.. Device class: 2.

Clearance details

Applicant: Inteware Co., Ltd.
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2018-12-31
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minxiong Township, Chiayi Country 62145, 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.