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 |