Last synced on 9 December 2022 at 11:04 pm

Monarch Platform, Urology

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213334
510(k) Type
Traditional
Applicant
Auris Health Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/2022
Days to Decision
205 days
Submission Type
Summary

Monarch Platform, Urology

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213334
510(k) Type
Traditional
Applicant
Auris Health Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/29/2022
Days to Decision
205 days
Submission Type
Summary