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FDA 510(k)

Smoklean

K-Number: K173108 · 2018-05-18

ApplicantSejong Medical Co., Ltd.
Decision Date2018-05-18
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Smoklean is the device name listed in this FDA 510(k) record. The listed applicant is Sejong Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K173108. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smoklean?

Smoklean is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Sejong Medical Co., Ltd.. The 510(k) number is K173108.

When did Smoklean receive FDA 510(k) clearance?

Smoklean received FDA 510(k) clearance on 2018-05-18, under 510(k) number K173108.

Who is the listed applicant for Smoklean?

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

What is the FDA product code for Smoklean?

The FDA product code for Smoklean is FYD.

Other records listing Sejong Medical Co., Ltd. as applicant

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Related Devices (Code: FYD)

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

View on FDA Database →

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

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