Smile-100 System— 510(k) K212965

Name: FDA 510(k) clearance K212965
Creator: U.S. Food and Drug Administration
Published: 2022-03-10

Substantially Equivalent

Niramai 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. Device class: 1.

Clearance details

Applicant: Niramai Health Analytix Private Limited
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2021-09-16
Decision date: 2022-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

Download summary PDF View on FDA.gov ↗

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