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FDA 510(k)

DUET-V (Model: ESK-3261DV)

K-Number: K233118 · 2025-01-03

ApplicantEunsung Global Corp
Decision Date2025-01-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUET-V (Model: ESK-3261DV) is the device name listed in this FDA 510(k) record. The listed applicant is Eunsung Global Corp. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K233118. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET-V (Model: ESK-3261DV)?

DUET-V (Model: ESK-3261DV) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Eunsung Global Corp. The 510(k) number is K233118.

When did DUET-V (Model: ESK-3261DV) receive FDA 510(k) clearance?

DUET-V (Model: ESK-3261DV) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K233118.

Who is the listed applicant for DUET-V (Model: ESK-3261DV)?

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

What is the FDA product code for DUET-V (Model: ESK-3261DV)?

The FDA product code for DUET-V (Model: ESK-3261DV) is GEI.

Related Devices (Code: GEI)

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

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

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