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GI Genius System 100 and GI Genius System 200

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231143
510(k) Type
Special
Applicant
Cosmo Artificial Intelligence - AI Ltd
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/19/2023
Days to Decision
28 days
Submission Type
Summary

GI Genius System 100 and GI Genius System 200

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231143
510(k) Type
Special
Applicant
Cosmo Artificial Intelligence - AI Ltd
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/19/2023
Days to Decision
28 days
Submission Type
Summary