Oculeve Intranasal Tear Neurostimulator Device
FDA 510(k) clearance DEN160030 · decided 2017-04-24
Clearance details
- K-number
- DEN160030
- Device name
- Oculeve Intranasal Tear Neurostimulator Device
- Applicant
- Oculeve, Inc.
- Decision
- Unknown
- Date received
- 2016-07-07
- Decision date
- 2017-04-24
- Days to decision
- 291 days
- Clearance type
- Direct
- Product code
- PQJ
- Device class
- 2
- Regulation number
- 886.5300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.