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aprevo® Digital Segmentation

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231955
510(k) Type
Traditional
Applicant
Carlsmed, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2023
Days to Decision
123 days
Submission Type
Summary

aprevo® Digital Segmentation

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231955
510(k) Type
Traditional
Applicant
Carlsmed, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2023
Days to Decision
123 days
Submission Type
Summary