TINNITUS SOUND GENERATOR MODULE
FDA 510(k) clearance K110932 · decided 2011-05-03
Clearance details
- K-number
- K110932
- Device name
- TINNITUS SOUND GENERATOR MODULE
- Applicant
- Gn Resound A/S
- Decision
- Substantially Equivalent
- Date received
- 2011-04-04
- Decision date
- 2011-05-03
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KLW
- Device class
- 2
- Regulation number
- 874.3400
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ballerup, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.