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FDA 510(k)

LX9max

K-Number: K203498 · 2021-07-02

Decision Date2021-07-02
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LX9max is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203498. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LX9max?

LX9max is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K203498.

When did LX9max receive FDA 510(k) clearance?

LX9max received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203498.

Who is the listed applicant for LX9max?

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

What is the FDA product code for LX9max?

The FDA product code for LX9max is IRP.

Other records listing Daesung Maref 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.

View all 10 devices →

Related Devices (Code: IRP)

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

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