510(k) K050653— TRANSEAR BONE CONDUCTION HEARING AID
Substantially EquivalentUnited Hearing Systems, Inc.
Clearance details
- Applicant
- United Hearing Systems, Inc.
- Product code
- Code LXB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Central Village, CT, US
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
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.