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 a medical device manufactured by Concha Labs. It received FDA 510(k) clearance on 2024-03-15 under approval 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. It is manufactured by Concha Labs. The 510(k) number is K233747.
When was Concha Sol Hearing Aids (CL-1001) approved by the FDA?
Concha Sol Hearing Aids (CL-1001) received FDA 510(k) clearance on 2024-03-15, under approval number K233747.
What company makes Concha Sol Hearing Aids (CL-1001)?
Concha Sol Hearing Aids (CL-1001) is manufactured by Concha Labs.
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.
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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.