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FDA 510(k)

Concha Sol Hearing Aids (CL-1001)

K-Number: K233747 · 2024-03-15

ApplicantConcha Labs
Decision Date2024-03-15
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Concha Sol Hearing Aids (CL-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Concha Labs. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K233747. 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 Concha Sol Hearing Aids (CL-1001)?

Concha Sol Hearing Aids (CL-1001) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Concha Labs. The 510(k) number is K233747.

When did Concha Sol Hearing Aids (CL-1001) receive FDA 510(k) clearance?

Concha Sol Hearing Aids (CL-1001) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233747.

Who is the listed applicant for Concha Sol Hearing Aids (CL-1001)?

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

What is the FDA product code for Concha Sol Hearing Aids (CL-1001)?

The FDA product code for Concha Sol Hearing Aids (CL-1001) is QUH.

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/SK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , 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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