510(k) DEN190026
- Device
- iTEAR Neurostimulator
- Applicant
- Olympic Ophthalmics, Inc.
- 510(k) number
- DEN190026
- Product code
- QKV
- Decision
- Unknown (DENG)
- Decision date
- 2020-05-01
- Date received
- 2019-05-15
- Regulation
- 886.5305
- Classification name
- Electromechanical Tear Stimulator
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michael Gertner
- Address
- 400 NW Gilman Blvd. #1370 Issaquah WA US 98027 98027
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QKV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | 2022-03-16 |