MEDO-Thyroid— 510(k) K203502

Substantially Equivalent

Medo DX Pte. , Ltd.

FDA 510(k) clearance K203502 for MEDO-Thyroid, Substantially Equivalent on 2021-04-23. Applicant: Medo DX Pte. , Ltd.. Device class: 2.

Clearance details

Applicant: Medo DX Pte. , Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-11-30
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

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