FDA 510(k)

AI100 with Shonit

K-Number: K221309 · 2023-09-19

ApplicantSigtuple Technologies Pvt. , Ltd.

Decision Date2023-09-19

Product CodeJOY

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

AI100 with Shonit is a medical device manufactured by Sigtuple Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-09-19 under approval number K221309. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI100 with Shonit?

AI100 with Shonit is a medical device that received FDA 510(k) clearance on 2023-09-19. It is manufactured by Sigtuple Technologies Pvt. , Ltd.. The 510(k) number is K221309.

When was AI100 with Shonit approved by the FDA?

AI100 with Shonit received FDA 510(k) clearance on 2023-09-19, under approval number K221309.

What company makes AI100 with Shonit?

AI100 with Shonit is manufactured by Sigtuple Technologies Pvt. , Ltd..

What is the FDA product code for AI100 with Shonit?

The FDA product code for AI100 with Shonit is JOY.

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Official Source

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