Smile-100 System— 510(k) K212965
Substantially EquivalentNiramai Health Analytix Private Limited
FDA 510(k) clearance K212965 for Smile-100 System, Substantially Equivalent on 2022-03-10. Applicant: Niramai Health Analytix Private Limited.
Clearance details
- Applicant
- Niramai Health Analytix Private Limited
- Product code
- Code LHQ
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bangalore, IN
Data sourced from openFDA. This site is unofficial and independent of the FDA.