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FDA 510(k)

Lumen 155-SF

K-Number: K223911 · 2023-10-17

ApplicantIntricon Corporation
Decision Date2023-10-17
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Lumen 155-SF is a medical device manufactured by Intricon Corporation. It received FDA 510(k) clearance on 2023-10-17 under approval number K223911. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumen 155-SF?

Lumen 155-SF is a medical device that received FDA 510(k) clearance on 2023-10-17. It is manufactured by Intricon Corporation. The 510(k) number is K223911.

When was Lumen 155-SF approved by the FDA?

Lumen 155-SF received FDA 510(k) clearance on 2023-10-17, under approval number K223911.

What company makes Lumen 155-SF?

Lumen 155-SF is manufactured by Intricon Corporation.

What is the FDA product code for Lumen 155-SF?

The FDA product code for Lumen 155-SF is QDD.

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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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