Last synced on 27 January 2023 at 11:04 pm

iSMILE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200908
510(k) Type
Traditional
Applicant
3D Diagnostix Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/2020
Days to Decision
260 days
Submission Type
Summary

iSMILE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200908
510(k) Type
Traditional
Applicant
3D Diagnostix Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/2020
Days to Decision
260 days
Submission Type
Summary