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FDA 510(k)

MEDO-Thyroid

K-Number: K203502 · 2021-04-23

ApplicantMedo DX Pte. , Ltd.
Decision Date2021-04-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDO-Thyroid is the device name listed in this FDA 510(k) record. The listed applicant is Medo DX Pte. , Ltd.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K203502. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDO-Thyroid?

MEDO-Thyroid is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Medo DX Pte. , Ltd.. The 510(k) number is K203502.

When did MEDO-Thyroid receive FDA 510(k) clearance?

MEDO-Thyroid received FDA 510(k) clearance on 2021-04-23, under 510(k) number K203502.

Who is the listed applicant for MEDO-Thyroid?

The FDA 510(k) record lists Medo DX Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDO-Thyroid?

The FDA product code for MEDO-Thyroid is QIH.

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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.

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Official Source

View on FDA Database →

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

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