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FDA 510(k)

REXMONO, PDREX

K-Number: K173779 · 2018-03-12

ApplicantSm Eng Co., Ltd.
Decision Date2018-03-12
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REXMONO, PDREX 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 2018-03-12 under 510(k) number K173779. 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 REXMONO, PDREX?

REXMONO, PDREX is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Sm Eng Co., Ltd.. The 510(k) number is K173779.

When did REXMONO, PDREX receive FDA 510(k) clearance?

REXMONO, PDREX received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173779.

Who is the listed applicant for REXMONO, PDREX?

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 REXMONO, PDREX?

The FDA product code for REXMONO, PDREX 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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