FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
iTEAR Neurostimulator
K Number: DEN190026
·
Decision May 1, 2020
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
1
Review Days
352
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Basic Information
- Device Name
- iTEAR Neurostimulator
- K Number
- DEN190026
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 886.5305
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Applicant
- Olympic Ophthalmics, Inc.
- Date Received
- May 15, 2019
- Decision Date
- May 1, 2020
- Product Code
- QKV
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| QKV | Electromechanical Tear Stimulator | FDA class 2 | Ophthalmic |
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