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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 the device name listed in this FDA 510(k) record. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) 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. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. The 510(k) number is K221309.

When did AI100 with Shonit receive FDA 510(k) clearance?

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

Who is the listed applicant for AI100 with Shonit?

The FDA 510(k) record lists Sigtuple Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI100 with Shonit?

The FDA product code for AI100 with Shonit is JOY.

Related Devices (Code: JOY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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