FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Tinnitus Sound Generator Module
K Number: K180495
·
Decision Nov 30, 2018
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
4
Review Days
277
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Basic Information
- Device Name
- Tinnitus Sound Generator Module
- K Number
- K180495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GN Hearing A/S
- Date Received
- February 26, 2018
- Decision Date
- November 30, 2018
- Product Code
- KLW
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KLW | Masker, Tinnitus | FDA class 2 | Ear, Nose, Throat |
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