FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Tinnitus Sound Generator Module
K Number: K193303
·
Decision Feb 20, 2020
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
75
Applicant Total
4
Review Days
83
Basic Information
- Device Name
- Tinnitus Sound Generator Module
- K Number
- K193303
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GN Hearing A/S
- Date Received
- November 29, 2019
- Decision Date
- February 20, 2020
- 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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