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HepaFat-AI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201039
510(k) Type
Traditional
Applicant
Resonance Health Analysis Services Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/7/2020
Days to Decision
231 days
Submission Type
Summary