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Brainomix 360 Triage ICH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231195
510(k) Type
Traditional
Applicant
Brainomix Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/27/2023
Days to Decision
91 days
Submission Type
Summary

Brainomix 360 Triage ICH

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231195
510(k) Type
Traditional
Applicant
Brainomix Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/27/2023
Days to Decision
91 days
Submission Type
Summary