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FDA 510(k)

CWM-930S, FIXER DV9

K-Number: K233120 · 2024-05-23

ApplicantChungwoo Co., Ltd.
Decision Date2024-05-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CWM-930S, FIXER DV9 is the device name listed in this FDA 510(k) record. The listed applicant is Chungwoo Co., Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233120. 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 CWM-930S, FIXER DV9?

CWM-930S, FIXER DV9 is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Chungwoo Co., Ltd.. The 510(k) number is K233120.

When did CWM-930S, FIXER DV9 receive FDA 510(k) clearance?

CWM-930S, FIXER DV9 received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233120.

Who is the listed applicant for CWM-930S, FIXER DV9?

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

What is the FDA product code for CWM-930S, FIXER DV9?

The FDA product code for CWM-930S, FIXER DV9 is GEI.

Other records listing Chungwoo Co., Ltd. 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.

K222709Retraction, CWM-910T, APOLEX Tite

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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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