FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EarLens Contact Hearing Device
K Number: DEN150002
·
Decision Sep 29, 2015
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
270
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Basic Information
- Device Name
- EarLens Contact Hearing Device
- K Number
- DEN150002
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 874.3315
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Unknown
- Applicant
- Earlens Corporation
- Date Received
- January 2, 2015
- Decision Date
- September 29, 2015
- Product Code
- PLK
- 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 |
|---|---|---|---|
| PLK | Tympanic Membrane Direct Contact Hearing Aid | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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