Source document or public record
FDA 510(k) K221309 — AI100 with Shonit
FDA 510(k) index record K221309. Device: AI100 with Shonit. Applicant as listed: Sigtuple Technologies Pvt. , Ltd.. Decision date: 2023-09-19.
Source
"device_name": "AI100 with Shonit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K221309.
Device name: AI100 with Shonit. Applicant as listed: Sigtuple Technologies Pvt. , Ltd..
Decision date: 2023-09-19. Decision wording: Substantially Equivalent.
Product code: JOY. Regulation: 21 CFR 864.5260. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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