Class Class II

GI Genius System 100 and GI Genius System 200 (K231143)

K231143 2023-05-19 Special
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Description

GI Genius System 100 and GI Genius System 200 by Cosmo Artificial Intelligence - Ai, Ltd. — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK231143
Clearance Date2023-05-19
Clearance TypeSpecial
Product CodeQNP
Regulation Number876.1520

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