The following data is part of a De Novo classification by Olympic Ophthalmics, Inc. with the FDA for Itear Neurostimulator.
DeNovo ID | DEN190026 |
Device Name: | ITEAR Neurostimulator |
Classification | Electromechanical Tear Stimulator |
Applicant | Olympic Ophthalmics, Inc. 400 Nw Gilman Blvd. #1370 Issaquah, WA 98027 |
Contact | Michael Gertner |
Product Code | QKV |
CFR Regulation Number | 886.5305 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Ophthalmic |
Classification Advisory | Ophthalmic |
Type | Direct |
Date Received | 2019-05-15 |
Decision Date | 2020-05-01 |
Reclassification Order: | Reclassification Order |