AI100 with Shonit— 510(k) K221309

Name: FDA 510(k) clearance K221309
Creator: U.S. Food and Drug Administration
Published: 2023-09-19

Substantially Equivalent

Sigtuple Technologies Pvt. , Ltd.

FDA 510(k) clearance K221309 for AI100 with Shonit, Substantially Equivalent on 2023-09-19. Applicant: Sigtuple Technologies Pvt. , Ltd.. Device class: 2.

Clearance details

Applicant: Sigtuple Technologies Pvt. , Ltd.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 2022-05-05
Decision date: 2023-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

Download summary PDF View on FDA.gov ↗

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