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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K221309
Device Name AI100 with Shonit
Applicant
Sigtuple Technologies Pvt. , Ltd.
First Floor, L-162, 14th Cross Rd., Sector 6, Hsr Layout
Bangalore,  IN 560102
Applicant Contact Tathagato Rai Dastidar
Correspondent
Axteria Biomed Consulting, Inc.
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Jinjie Hu
Regulation Number864.5260
Classification Product Code
JOY  
Date Received05/05/2022
Decision Date 09/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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