FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
K Number: K093715
·
Decision Dec 22, 2010
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
1
Review Days
386
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Basic Information
- Device Name
- EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
- K Number
- K093715
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magnatone Hearing Aid Corp. Dba Persona Medical
- Date Received
- December 1, 2009
- Decision Date
- December 22, 2010
- 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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