ZEN PROGRAM (MIND 440 HEARING AID)
FDA 510(k) clearance K080955 · decided 2008-06-27
Clearance details
- K-number
- K080955
- Device name
- ZEN PROGRAM (MIND 440 HEARING AID)
- Applicant
- Widex Hearing Aid Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-03
- Decision date
- 2008-06-27
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KLW
- Device class
- 2
- Regulation number
- 874.3400
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lisle, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.