The following data is part of a premarket notification filed by Niramai Health Analytix Private Limited with the FDA for Smile-100 System.
| Device ID | K212965 |
| 510k Number | K212965 |
| Device Name: | Smile-100 System |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | Niramai Health Analytix Private Limited Innova Pearl, Ground Floor, No.17, 5th Block, Koramangala Industrial Layout, Koramangala Bangalore, IN 560095 |
| Contact | Geetha Manjunath |
| Correspondent | Yolanda Smith Smith Associates 1468 Harvell Avenue Crofton, MD 21114 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2022-03-10 |