Clearance Summary
Smile-100 System received FDA 510(k) clearance under submission number K212965, sponsored by Niramai Health Analytix Private Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2022-03-10.
- Submission: K212965
- Applicant / Sponsor: Niramai Health Analytix Private Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2022-03-10
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.