Clearance Summary
AI100 with Shonit received FDA 510(k) clearance under submission number K221309, sponsored by Sigtuple Technologies Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2023-09-19.
- Submission: K221309
- Applicant / Sponsor: Sigtuple Technologies Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 2023-09-19
Classification & Regulation
This clearance is catalogued under FDA product code JOY and 21 CFR 864.5260, within the Hematology review panel as a Class II device.