TRANSEAR BONE CONDUCTION HEARING AID
FDA 510(k) clearance K050653 · decided 2005-07-01
Clearance details
- K-number
- K050653
- Device name
- TRANSEAR BONE CONDUCTION HEARING AID
- Applicant
- United Hearing Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-11
- Decision date
- 2005-07-01
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Central Village, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.