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FDA 510(k)

S-Mono

K-Number: K221317 · 2023-01-13

ApplicantShinhung Mst Co., Ltd.
Decision Date2023-01-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-Mono is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221317. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Mono?

S-Mono is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K221317.

When did S-Mono receive FDA 510(k) clearance?

S-Mono received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221317.

Who is the listed applicant for S-Mono?

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

What is the FDA product code for S-Mono?

The FDA product code for S-Mono is DZE.

Other records listing Shinhung Mst 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: DZE)

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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