FDA 510(k)

Lumen 155-SF

K-Number: K223911 · 2023-10-17

Decision Date2023-10-17

Product CodeQDD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Lumen 155-SF is the device name listed in this FDA 510(k) record. The listed applicant is Intricon Corporation. It received FDA 510(k) clearance on 2023-10-17 under 510(k) 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. The listed applicant is Intricon Corporation. The 510(k) number is K223911.

When did Lumen 155-SF receive FDA 510(k) clearance?

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

Who is the listed applicant for Lumen 155-SF?

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

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

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

Related Devices (Code: QDD)

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.

K220403Vibe SF Self-Fitting Hearing AidWsaud A/S K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid K213424Jabra Enhance PlusGN Hearing A/S K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company K211008Bose SoundControl Hearing AidsBose Corporation

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.