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FDA 510(k)

Smile-100 System

K-Number: K212965 · 2022-03-10

ApplicantNiramai Health Analytix Private Limited
Decision Date2022-03-10
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Smile-100 System is a medical device manufactured by Niramai Health Analytix Private Limited. It received FDA 510(k) clearance on 2022-03-10 under approval number K212965. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smile-100 System?

Smile-100 System is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Niramai Health Analytix Private Limited. The 510(k) number is K212965.

When was Smile-100 System approved by the FDA?

Smile-100 System received FDA 510(k) clearance on 2022-03-10, under approval number K212965.

What company makes Smile-100 System?

Smile-100 System is manufactured by Niramai Health Analytix Private Limited.

What is the FDA product code for Smile-100 System?

The FDA product code for Smile-100 System is LHQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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