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FDA 510(k)

LumiNE US; Lumi

K-Number: K240094 · 2024-09-10

ApplicantAugmedit B.V.
Decision Date2024-09-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LumiNE US; Lumi is the device name listed in this FDA 510(k) record. The listed applicant is Augmedit B.V.. It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K240094. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiNE US; Lumi?

LumiNE US; Lumi is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Augmedit B.V.. The 510(k) number is K240094.

When did LumiNE US; Lumi receive FDA 510(k) clearance?

LumiNE US; Lumi received FDA 510(k) clearance on 2024-09-10, under 510(k) number K240094.

Who is the listed applicant for LumiNE US; Lumi?

The FDA 510(k) record lists Augmedit B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumiNE US; Lumi?

The FDA product code for LumiNE US; Lumi is QIH.

Related Devices (Code: QIH)

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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