DeviceClearance

Concha Sol Hearing Aids (CL-1001)— 510(k) K233747

Substantially Equivalent

Concha Labs

FDA 510(k) clearance K233747 for Concha Sol Hearing Aids (CL-1001), Substantially Equivalent on 2024-03-15. Applicant: Concha Labs. Device class: 2.

Clearance details

Applicant
Concha Labs
Product code
Code QUH
Device class
Class 2
Regulation
21 CFR 874.3325
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Mateo, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code QUH

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Adverse events under product code QUH

product code QUH
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.