Last synced on 23 September 2022 at 11:05 pm

Apogee

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200401
510(k) Type
Traditional
Applicant
Incoba Ltd. d/b/a Dynaris
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2020
Days to Decision
270 days
Submission Type
Summary

Apogee

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200401
510(k) Type
Traditional
Applicant
Incoba Ltd. d/b/a Dynaris
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2020
Days to Decision
270 days
Submission Type
Summary