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FDA 510(k)

Agnes

K-Number: K192728 · 2019-10-24

ApplicantAgnes Medical Co., Ltd.
Decision Date2019-10-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Agnes is the device name listed in this FDA 510(k) record. The listed applicant is Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K192728. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agnes?

Agnes is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Agnes Medical Co., Ltd.. The 510(k) number is K192728.

When did Agnes receive FDA 510(k) clearance?

Agnes received FDA 510(k) clearance on 2019-10-24, under 510(k) number K192728.

Who is the listed applicant for Agnes?

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

What is the FDA product code for Agnes?

The FDA product code for Agnes is GEI.

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

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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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