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FDA 510(k)

CuratOR EX3242-FD

K-Number: K231066 · 2023-12-18

Decision Date2023-12-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CuratOR EX3242-FD is the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2023-12-18 under 510(k) number K231066. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuratOR EX3242-FD?

CuratOR EX3242-FD is a medical device that received FDA 510(k) clearance on 2023-12-18. The listed applicant is Eizo Corporation. The 510(k) number is K231066.

When did CuratOR EX3242-FD receive FDA 510(k) clearance?

CuratOR EX3242-FD received FDA 510(k) clearance on 2023-12-18, under 510(k) number K231066.

Who is the listed applicant for CuratOR EX3242-FD?

The FDA 510(k) record lists Eizo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CuratOR EX3242-FD?

The FDA product code for CuratOR EX3242-FD is GCJ.

Other records listing Eizo Corporation as applicant

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.

View all 21 devices →

Related Devices (Code: GCJ)

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.

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.