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FDA 510(k)

REXSIN

K-Number: K200392 · 2020-07-07

ApplicantSm Eng Co., Ltd.
Decision Date2020-07-07
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REXSIN is the device name listed in this FDA 510(k) record. The listed applicant is Sm Eng Co., Ltd.. It received FDA 510(k) clearance on 2020-07-07 under 510(k) number K200392. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REXSIN?

REXSIN is a medical device that received FDA 510(k) clearance on 2020-07-07. The listed applicant is Sm Eng Co., Ltd.. The 510(k) number is K200392.

When did REXSIN receive FDA 510(k) clearance?

REXSIN received FDA 510(k) clearance on 2020-07-07, under 510(k) number K200392.

Who is the listed applicant for REXSIN?

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

What is the FDA product code for REXSIN?

The FDA product code for REXSIN is GAM.

Other records listing Sm Eng 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.

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Related Devices (Code: GAM)

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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