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FDA 510(k)

Intrisound™ Tuned Lumen® 155 Hearing Aids

K-Number: K223848 · 2023-09-08

ApplicantTuned , Ltd.
Decision Date2023-09-08
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Intrisound™ Tuned Lumen® 155 Hearing Aids is the device name listed in this FDA 510(k) record. The listed applicant is Tuned , Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K223848. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intrisound™ Tuned Lumen® 155 Hearing Aids?

Intrisound™ Tuned Lumen® 155 Hearing Aids is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Tuned , Ltd.. The 510(k) number is K223848.

When did Intrisound™ Tuned Lumen® 155 Hearing Aids receive FDA 510(k) clearance?

Intrisound™ Tuned Lumen® 155 Hearing Aids received FDA 510(k) clearance on 2023-09-08, under 510(k) number K223848.

Who is the listed applicant for Intrisound™ Tuned Lumen® 155 Hearing Aids?

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

What is the FDA product code for Intrisound™ Tuned Lumen® 155 Hearing Aids?

The FDA product code for Intrisound™ Tuned Lumen® 155 Hearing Aids is QUH.

Other records listing Tuned , 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.

K251208Tuned Self-Fitting Mobile App

Related Devices (Code: QUH)

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.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG

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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