Last synced on 27 January 2023 at 11:04 pm

Monarch Platform

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211493
510(k) Type
Special
Applicant
Auris Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/9/2021
Days to Decision
57 days
Submission Type
Summary

Monarch Platform

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211493
510(k) Type
Special
Applicant
Auris Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/9/2021
Days to Decision
57 days
Submission Type
Summary