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510(k) K221309

AI100 with Shonit by Sigtuple Technologies Pvt. , Ltd. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2023
Date Received
May 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

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