The following data is part of a premarket notification filed by Forus Health Pvt. Ltd. with the FDA for 3nethra Neo.
| Device ID | K183059 |
| 510k Number | K183059 |
| Device Name: | 3nethra Neo |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Forus Health Pvt. Ltd. #86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Road 5th Main Nr Colony Bengalura, IN 560019 |
| Contact | Shruti Kashinath |
| Correspondent | Shruti Kashinath Forus Health Pvt. Ltd. #86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Road 5th Main Nr Colony Bengalura, IN 560019 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2018-12-21 |
| Summary: | summary |